FDA Product Code
FDA Product Code DXJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2450
510(k) Clearances — 79 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). | Barco N.V. | 2026-09-30 | Traditional | PDF ↗ |
| K212003 | ESSENZ Patient Monitor | Livanova Deutschland, GmbH | 2021-11-10 | Special | PDF ↗ |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 | Traditional | PDF ↗ |
| K201162 | Essence 55SP Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2020-08-27 | Traditional | PDF ↗ |
| K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | 2018-07-26 | Traditional | PDF ↗ |
| K180534 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2018-07-16 | Traditional | PDF ↗ |
| K173381 | Nexxis OR | Barco N.V. | 2018-02-22 | Special | PDF ↗ |
| K172969 | Essence 55S Large Monitor System | Shenyang Torch-Bigtide Digital Technology Co., Ltd. | 2018-01-26 | Traditional | PDF ↗ |
| K170460 | Sorin Connect | Sorin Group Deutschland GmbH | 2017-06-08 | Special | PDF ↗ |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | 2017-04-21 | Special | PDF ↗ |
| K161880 | NIVR58-T kit | Barco N.V. | 2017-03-14 | Special | PDF ↗ |
| K161767 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boeblingen GmbH | 2017-01-27 | Traditional | PDF ↗ |
| K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016-09-15 | Special | PDF ↗ |
| K151366 | Philips CS770 IntelliSpace Critical Care and Anesthesia | Philips Medical Systems | 2015-10-30 | Traditional | PDF ↗ |
| K151736 | Philips IntelliVue GuardianSoftware | Philips Medizin Systeme Boblingen GmbH | 2015-10-21 | Special | PDF ↗ |
| K133994 | SIVR56-T KIT | Barco N.V. | 2014-12-01 | Traditional | PDF ↗ |
| K133882 | CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) | Ge Medical Systems Information Technologies, Inc. | 2014-04-30 | Traditional | PDF ↗ |
| K132488 | ZOLL CODE WRITER | ZOLL Medical Corporation | 2014-04-03 | Traditional | PDF ↗ |
| K131272 | SIREN EPCR SUITE | Medusa Medical Technologies, Inc. | 2014-01-03 | Traditional | PDF ↗ |
| K131919 | ZOLL EPCR IOS | ZOLL Medical Corporation | 2013-12-17 | Special | PDF ↗ |
| K131816 | SORIN CONNECT DATA MANAGEMENT SYSTEM | Sorin Group Deutschland GmbH | 2013-07-23 | Traditional | PDF ↗ |
| K122167 | NEXXIS OR | Barco N.V. | 2013-04-22 | Traditional | PDF ↗ |
| K113214 | TLINK DATA MANAGEMENT SYSTEM (DMS) | Terumo Cardiovascular Systems Corp. | 2012-02-07 | Traditional | PDF ↗ |
| K111905 | INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2011-10-04 | Abbreviated | PDF ↗ |
| K112645 | RADIFORCE LARGE MONITOR SYSTEM | Eizo GmbH | 2011-09-22 | Traditional | PDF ↗ |
| K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR | ZOLL Medical Corporation | 2011-05-13 | Traditional | PDF ↗ |
| K110085 | VANTAGE VIEW SYSTEM | St Jude Medical | 2011-01-26 | Traditional | PDF ↗ |
| K101474 | MD VISION SYSTEM | Perkins Healthcare Technologies | 2010-07-02 | Traditional | PDF ↗ |
| K100272 | INTELLIVUE CLINICAL INFORMATION PORTFOLIO | Philips Medical Systems | 2010-04-14 | Special | PDF ↗ |
| K083321 | CARDIO-VIEW | Curlview Igt, LLC | 2008-11-26 | Traditional | PDF ↗ |
| K073372 | ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) | Systemsone | 2007-12-07 | Traditional | PDF ↗ |
| K053356 | MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION | Ge Medical Systems Information Technologies | 2006-04-19 | Traditional | PDF ↗ |
| K013515 | INFINITY EXPLORER | Siemens Medical Solutions USA, Inc. | 2002-01-10 | Traditional | PDF ↗ |
| K001112 | GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC | General Electric Medical Systems Information Techn | 2000-06-14 | Traditional | PDF ↗ |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Hewlett-Packard Co. | 1999-08-31 | Special | PDF ↗ |
| K942685 | ECG REVIEW STATION | Mortara Instrument, Inc. | 1997-08-12 | Traditional | PDF ↗ |
| K962811 | SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATION | Spacelabs Medical, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K945277 | HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR | Hewlett-Packard Co. | 1995-01-30 | Traditional | PDF ↗ |
| K934093 | 580CDR DISPLAY DRIVER | Vidco, Inc. | 1994-08-18 | Traditional | PDF ↗ |
| K932894 | 620CSR DISPLAY DRIVER | Vidco, Inc. | 1994-06-20 | Traditional | PDF ↗ |
| K926219 | 516YT DISPLAY DRIVER | Vidco, Inc. | 1993-12-16 | Traditional | PDF ↗ |
| K926162 | 580CD DISPLAY DRIVER | Vidco, Inc. | 1993-11-08 | Traditional | PDF ↗ |
| K932724 | SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY | Spacelabs Medical, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K905788 | MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM | Hewlett-Packard Co. | 1991-06-06 | Traditional | PDF ↗ |
| K901072 | CENTRALSCOPE 12 | Marquette Electronics, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K902334 | MONITOR, MODEL 2817 | Esaote Biomedica Spa | 1990-06-26 | Traditional | PDF ↗ |
| K901884 | 7620 REMOTE CENTRAL STATION REPEATER | Marquette Electronics, Inc. | 1990-06-12 | Traditional | PDF ↗ |
| K884423 | HORIZON DISPLAY CONTROLLER PART # 266-200-010 | Mennen Medical, Inc. | 1989-05-31 | Traditional | PDF ↗ |
| K890353 | SMDS460 SURGICAL MONITOR DISPLAY SYSTEM | Vidco, Inc. | 1989-03-02 | Traditional | PDF ↗ |
| K883973 | MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A | Nihon Kohden America, Inc. | 1988-11-09 | Traditional | PDF ↗ |
| K883031 | Q-CATH RM | Quinton, Inc. | 1988-09-20 | Traditional | PDF ↗ |
| K873774 | M300 MONITOR/CONTROLLER T500 TREADMILL | Burdick Corp. | 1987-11-06 | Traditional | PDF ↗ |
| K854372 | VM 781 SLAVE SCOPE | Nihon Kohden America, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K851496 | ECG MONITOR MODEL RM102 | Honeywell, Inc. | 1985-07-24 | Traditional | PDF ↗ |
| K851628 | RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO | Eaton Medical Group | 1985-06-27 | Traditional | PDF ↗ |
| K851400 | SIRECUST 420 PATIENT DIALOG MONITOR | Siemens Medical Solutions USA, Inc. | 1985-06-26 | Traditional | PDF ↗ |
| K850343 | DISPLAY MONITOR (VD-711RA-VD-712RA) | Nihon Kohden America, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844650 | DR-2C | General Devices | 1985-01-22 | Traditional | PDF ↗ |
| K840209 | SERVOMED MEDIVISION SCOPE SMV-235 | Litton Medical Electronics | 1984-09-20 | Traditional | PDF ↗ |
| K833819 | M305 | Burkick Corp. | 1984-05-09 | Traditional | PDF ↗ |
| K832022 | SERVOMED SMC 108/111-426-24, 111-426 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K831782 | SERVOMED BASIC BEDSIDE UNIT SMV 107 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K831781 | SERVOMED BASIC BEDSIDE UNIT SMVIII W | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K831783 | SERVOMED BASIC BEDSIDE UNIT SMV 104 | Litton Medical Electronics | 1983-11-16 | Traditional | PDF ↗ |
| K830899 | THREE CHANNEL MONITOR SERIES 6700 | Marquette Electronics, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K822517 | SINGLE CHANNEL NONFADE OSCILLOSCOPE | Quinton, Inc. | 1982-09-14 | Traditional | PDF ↗ |
| K821491 | 35MM ANGIOGRAM VIEWER ANALYZER | Birtcher Corp. | 1982-07-08 | Traditional | PDF ↗ |
| K811911 | SINGLE CHANNEL NON-FADE OSCILLOSCOPE | Quinton, Inc. | 1981-07-28 | Traditional | PDF ↗ |
| K810165 | DUAL TRACE VIDEO MONITOR VM 410 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810168 | SLAVE MONITORS DC109 & VS109 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810164 | VC 430 VIDEO CONVERTER | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K803123 | CRT DISPLAY #1310B | Hewlett-Packard Co. | 1981-01-13 | Traditional | PDF ↗ |
| K801000 | LARGE SCREEN CRT DISPLAY #1311B | Hewlett-Packard Co. | 1980-05-28 | Traditional | PDF ↗ |
| K781256 | CATHODE RAY TUBE MED. DISPLAY | Rae Medical Corp. | 1978-09-20 | Traditional | PDF ↗ |
| K780782 | M. 1336S CATHODE-RAY TUBE DISPLAY | Hewlett-Packard Co. | 1978-06-14 | Traditional | PDF ↗ |
| K780425 | BIOPHYSICAL MONITORING SYSTEM | Gould, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K770279 | MONITOR, PORTABLE, PART #431-010 | Mennen Greatbatch Electonics | 1977-02-24 | Traditional | PDF ↗ |
| K760721 | MEDICAL OSCILLOSCOPE MEMORY SCOPE | Abbott Laboratories | 1976-10-06 | Traditional | PDF ↗ |
| K760523 | MONITOR SCOPE | Hewlett-Packard Co. | 1976-09-03 | Traditional | PDF ↗ |
Product code DXJ · Class II · Cardiovascular. Data: openFDA.