FDA Product Code
FDA Product Code DQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 727 records · page 2 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191420 | Reusable SpO2 Sensor | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-10-11 | Traditional | PDF ↗ |
| K191417 | Belun Ring | Belun Technology Company Limited | 2019-10-10 | Traditional | PDF ↗ |
| K190869 | Pulse Oximeter | Shenzhen Aeon Technology Co., Ltd. | 2019-09-13 | Traditional | PDF ↗ |
| K190792 | BB-613WP | Biobeat Technologies , Ltd. | 2019-08-22 | Traditional | PDF ↗ |
| K190399 | Beddr 200 System | Hancock Medical, Inc. | 2019-08-05 | Traditional | PDF ↗ |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-06-25 | Special | PDF ↗ |
| K183277 | SpO2 Sensor | Shenzhen Upnmed Equipment Co., Ltd. | 2019-05-15 | Traditional | PDF ↗ |
| K181352 | Loop System | Spry Health, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K181738 | Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors | Surgical Instrument Service and Savings Inc (Dba Medline | 2019-03-22 | Traditional | PDF ↗ |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and Accessories | Masimo Corporation | 2019-03-22 | Traditional | PDF ↗ |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K183556 | oCare Wrist Pulse Oximeter | Taiwan Biophotonic Corporation | 2019-02-15 | Traditional | PDF ↗ |
| K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019-01-23 | Traditional | PDF ↗ |
| K180380 | vital signs monitor | Edan Instruments, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K180685 | AS-3XX Series Fingertip Pulse Oximeter | Xiamen Acurio Instruments Co., Ltd. | 2018-11-29 | Traditional | PDF ↗ |
| K172792 | Handheld Pulse Oximeter, Model SP-20 | Shenzhen Creative Industry Co., Ltd. | 2018-11-13 | Traditional | PDF ↗ |
| K180046 | Masimo Rad-97 and Accessories | Masimo Corporation | 2018-10-23 | Traditional | PDF ↗ |
| K181503 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018-10-11 | Traditional | PDF ↗ |
| K181006 | BB-613 Watch Oximeter | Bio-Beat Technologies , Ltd. | 2018-09-21 | Traditional | PDF ↗ |
| K181270 | Disposable SpO2 Sensors, Reusable SpO2 Sensors | Orantech, Inc. | 2018-09-07 | Traditional | PDF ↗ |
| K173368 | Reusable & Disposable SpO2 Sensors | Shenzhen Coreray Technology, Ltd. | 2018-08-31 | Traditional | PDF ↗ |
| K172492 | Optical Topography System ETG-4100 | Hitachi Healthcare Americas | 2018-08-17 | Traditional | PDF ↗ |
| K173123 | Pulse Oximeter | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-08-13 | Traditional | PDF ↗ |
| K172616 | Pulse Oximeter | Beijing Safe Heart Technology , Ltd. | 2018-07-27 | Traditional | PDF ↗ |
| K172981 | Reusable SpO2 Sensors, Disposable SpO2 Sensors | APK Technology Co., Ltd. | 2018-06-08 | Traditional | PDF ↗ |
| K173045 | Oximeter | Shenzhen Greatmade Tech Limited | 2018-06-05 | Traditional | PDF ↗ |
| K180174 | Belun Ring | Belun Technology Company Limited | 2018-05-29 | Traditional | PDF ↗ |
| K172625 | Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor | Nonin Medical, Inc. | 2018-05-11 | Traditional | PDF ↗ |
| K172141 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2018-04-04 | Traditional | PDF ↗ |
| K171241 | Pulse Oximeter | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2018-03-27 | Traditional | PDF ↗ |
| K172366 | Wrist Pulse Oximeter | Beijing Choice Electronic Technology Co., Ltd. | 2018-03-16 | Traditional | PDF ↗ |
| K172482 | The Nellcor pulse oximetry monitor interface cable | Covidien | 2017-12-15 | Traditional | PDF ↗ |
| K170965 | Fingertip Pulse Oximeter | Shenzhen Jumper Medical Equipment Co., Ltd. | 2017-11-03 | Special | PDF ↗ |
| K163135 | Finger Pulse Oximeter | Shenzhen Fitfaith Technology Co.,Ltd | 2017-09-19 | Traditional | PDF ↗ |
| K171423 | Nasal Alar SpO2 Sensor | Xhale, Inc. | 2017-07-27 | Traditional | PDF ↗ |
| K163382 | Oxitone 1000 | Oxitone Medical , Ltd. | 2017-05-09 | Traditional | PDF ↗ |
| K161938 | Fingertip Pulse Oximeter | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2017-05-08 | Traditional | PDF ↗ |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2017-03-03 | Traditional | PDF ↗ |
| K162014 | Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) | Bluepoint Medical GmbH & Co. KG | 2017-02-06 | Traditional | PDF ↗ |
| K153184 | Caremed Reusable & Disposable SPO2 Sensors | Shenzhen Caremed Medical Technology Co., Ltd. | 2017-01-04 | Traditional | PDF ↗ |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Masimo Corporation | 2016-12-28 | Traditional | PDF ↗ |
| K160231 | Model X-100C CO-Met Oximetry System | Nonin Medical, Inc. | 2016-12-23 | Traditional | PDF ↗ |
| K160940 | Masimo Disposable Transflectance Forehead Sensor | Masimo Corporation | 2016-11-23 | Traditional | PDF ↗ |
| K153021 | Fingertip Pulse Oximeter A310 | Amemo, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-14 | Traditional | PDF ↗ |
| K161560 | Fingertip Pulse Oximeter MD300CN310 | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-05 | Traditional | PDF ↗ |
| K160582 | WiCap | Athena Gtx | 2016-09-02 | Abbreviated | PDF ↗ |
| K152390 | Medke Oximetry Finger Sensor | Shenzhen Medke Technology Co., Ltd. | 2016-08-18 | Traditional | PDF ↗ |
| K152091 | Fingertip Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-18 | Traditional | PDF ↗ |
| K152089 | Wrist Pulse Oximeter | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-17 | Traditional | PDF ↗ |
| K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso | Nonin Medical, Inc. | 2016-08-05 | Traditional | PDF ↗ |
| K152563 | Pulse Oximeter (MD300M/MD300K2) | Beijing Choice Electronic Technology Co., Ltd. | 2016-04-18 | Traditional | PDF ↗ |
| K151024 | Finger Type Pulse Oximeter | Taidoc Technology Corporation | 2016-03-02 | Traditional | PDF ↗ |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D | Guangdong Biolight Meditech Co., Ltd. | 2016-01-06 | Traditional | PDF ↗ |
| K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015-10-22 | Traditional | PDF ↗ |
| K151206 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-08-28 | Traditional | PDF ↗ |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 | Shenzhen Creative Industry Co., Ltd. | 2015-06-03 | Special | PDF ↗ |
| K141362 | PULSE OXIMETER CMS50EW | Contec Medical Systems Co.,Ltd | 2015-04-23 | Traditional | PDF ↗ |
| K142687 | Pulse Oximeter | Shanghai Berry Electronic Tech Co., Ltd. | 2015-04-13 | Traditional | PDF ↗ |
| K142865 | Nellcor Bedside SpO2 Patient Monitoring System | Covidien, LLC | 2015-03-26 | Traditional | PDF ↗ |
| K142959 | Vyntus Walk | Carefusion Germany 234 GmbH | 2015-03-20 | Traditional | PDF ↗ |
| K143216 | Assurance Alar / Nasal SpO2 Sensor | Xhale, Inc. | 2015-03-17 | Traditional | PDF ↗ |
| K141518 | Nellcor Bedside Respiratory Patient Monitoring System | Covidien | 2015-03-05 | Traditional | PDF ↗ |
| K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-02-20 | Traditional | PDF ↗ |
| K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015-02-06 | Traditional | PDF ↗ |
| K142209 | Pulse oximeter NBM-200 | Orsense, Ltd. | 2015-01-16 | Special | PDF ↗ |
| K141024 | EXTERNAL PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-01-13 | Traditional | PDF ↗ |
| K141105 | PULSE OXIMETER | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2014-12-04 | Traditional | PDF ↗ |
| K141542 | NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) | Covidien, LLC | 2014-10-02 | Traditional | PDF ↗ |
| K140582 | FINGERTIP PULSE OXIMETER | Shenzhen Jumper Medical Equipment Co., Ltd. | 2014-08-28 | Traditional | PDF ↗ |
| K141128 | FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2014-08-13 | Traditional | PDF ↗ |
| K132516 | OXIPROBE E (OXIPROBE) | Bio Medical Technologies Co., Ltd. | 2014-07-30 | Traditional | PDF ↗ |
| K140682 | FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2014-07-17 | Traditional | PDF ↗ |
| K140785 | PULSE OXIMETER | Nonin Medical, Inc. | 2014-07-07 | Traditional | PDF ↗ |
| K133064 | MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31 | Envitec-Wismar GmbH | 2014-05-02 | Traditional | PDF ↗ |
| K133090 | OXICARE FINGERTIP PULSE OXIMETER | Delbio Incorporation | 2014-02-28 | Special | PDF ↗ |
| K132402 | SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM | Nonin Medical, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K130320 | BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW | Covidien | 2014-02-04 | Traditional | PDF ↗ |
| K124041 | NBM-200MP | Orsense, Ltd. | 2013-10-17 | Traditional | PDF ↗ |
| K131047 | FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-10-16 | Traditional | PDF ↗ |
| K130947 | FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-10-03 | Traditional | PDF ↗ |
| K132696 | TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR | GE Healthcare Finland Oy | 2013-09-27 | Special | PDF ↗ |
| K131111 | IHEALTH FINGERTIP PULSE OXIMETER | Andon Health Co, Ltd. | 2013-09-11 | Traditional | PDF ↗ |
| K131021 | PULSE OXIMETER | Nonin Medical, Inc. | 2013-09-11 | Traditional | PDF ↗ |
| K131818 | VITAL SIGNS MONITOR | Edan Instruments, Inc. | 2013-08-30 | Special | PDF ↗ |
| K123797 | NT1D VITAL SIGNS MONITOR | New Tech, Inc. | 2013-08-27 | Traditional | PDF ↗ |
| K123801 | FINGER PULSE OXIMETER | Shenzhen Kingyield Technology Co., Ltd. | 2013-05-28 | Traditional | PDF ↗ |
| K123871 | FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-05-10 | Special | PDF ↗ |
| K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2013-05-09 | Traditional | PDF ↗ |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | Masimo Corporation | 2013-04-26 | Traditional | PDF ↗ |
| K122996 | ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085 | Xhale | 2013-04-10 | Traditional | PDF ↗ |
| K113727 | SHENZHEN MED-LINK PULSE OXIMETER PROBE | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2013-03-21 | Traditional | PDF ↗ |
| K122046 | WRIST PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2013-02-04 | Traditional | PDF ↗ |
| K122927 | OXICARE FINGERTIP PULSE OXIMETER | Delbio Incorporated | 2012-12-20 | Traditional | PDF ↗ |
| K120502 | PC-60NW FINGERTIP OXIMETER | Shenzhen Creative Industry Co., Ltd. | 2012-12-07 | Abbreviated | PDF ↗ |
| K121697 | FINGERTIP PULSE OXIMETER | Andon Health Co, Ltd. | 2012-10-15 | Traditional | PDF ↗ |
| K121806 | BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE | Covidien | 2012-09-28 | Abbreviated | PDF ↗ |
| K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS | Masimo Corporation | 2012-09-19 | Traditional | PDF ↗ |
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | Masimo Corporation | 2012-09-07 | Special | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.