FDA Product Code
FDA Product Code DPS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2340
510(k) Clearances — 578 records · page 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133622 | MAC 2000 ECG ANALYSIS SYSTEM | Wipro GE Healthcare | 2014-01-23 | Traditional | PDF ↗ |
| K131819 | PC ECG | Edan Instruments, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K131262 | DIGITAL ELECTROCARDIOGRAPHS | Sonoscape Company Limited | 2013-11-14 | Traditional | PDF ↗ |
| K132068 | PHILIPS DXL 12/16-LEAD ECG ALGORITHM | Philips Medical Systems | 2013-09-26 | Special | PDF ↗ |
| K130409 | ALIVECOR HEART MONITOR | AliveCor, Inc. | 2013-09-06 | Traditional | PDF ↗ |
| K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS | Spacelabs Healthcare, Ltd. | 2013-07-23 | Traditional | PDF ↗ |
| K131572 | MICRO AMBULATORY ECG RECORDER | Dimetek Digital Medical Technologies, Ltd. | 2013-07-22 | Traditional | PDF ↗ |
| K131573 | CP150 ELECTROCARDIOGRAPH | Welch Allyn, Inc. | 2013-07-03 | Special | PDF ↗ |
| K121825 | CS-MAG II | Biomagnetik-Park GmbH | 2013-03-11 | Traditional | PDF ↗ |
| K123816 | DIGITAL ELECTROCARDIOGRAPHS | Shenzhen Biocare Electronics Co., Ltd. | 2013-02-27 | Special | PDF ↗ |
| K123217 | CARDEASCREEN | Cardea Associates, Inc. | 2013-02-05 | Traditional | PDF ↗ |
| K120770 | QT GUARD PLUS ANALYSIS SYSTEM | Ge Medical Systems Information Technologies | 2012-12-06 | Traditional | PDF ↗ |
| K122356 | ALIVECOR HEART MONITOR FOR IPHONE | AliveCor, Inc. | 2012-11-19 | Traditional | PDF ↗ |
| K122712 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Electronics Co., Ltd. | 2012-10-25 | Special | PDF ↗ |
| K122073 | ELI 280 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2012-08-02 | Special | PDF ↗ |
| K112622 | HANDHELD ECG MONITOR | Beijing Choice Electronic Technololgy Co., Ltd. | 2012-07-19 | Traditional | PDF ↗ |
| K120865 | RSCRIBE ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2012-07-19 | Special | PDF ↗ |
| K113306 | CARDIO 7 | Bionet Co., Ltd. | 2012-07-16 | Traditional | PDF ↗ |
| K121009 | HEARTCHECK ECG PEN WITH GEMS HOME | Cardiocomm Solutions, Inc. | 2012-05-17 | Traditional | PDF ↗ |
| K113485 | ELECTROCARDIOGRAPH | Shenzhen Carewell Electronics Co., Ltd. | 2012-04-25 | Traditional | PDF ↗ |
| K113144 | PAGEWRITER TC 20, 30, 50, 70 | Philips Medical Systems | 2012-04-03 | Traditional | PDF ↗ |
| K120188 | ELECTROCARDIOGRAPH | Edan Instruments, Inc. | 2012-03-16 | Special | PDF ↗ |
| K112959 | CALG-STR EXERCISE ECG ANALYSIS ALGORITHM | Philips Health Care | 2012-01-26 | Traditional | PDF ↗ |
| K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME | Cardiocomm Solutions, Inc. | 2011-12-22 | Traditional | PDF ↗ |
| K113234 | MOBCARDIO SYSTEM | Mobhealth Incorporation | 2011-11-17 | Traditional | PDF ↗ |
| K102378 | VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI | Vectracor, Inc. | 2011-11-02 | Traditional | PDF ↗ |
| K103791 | PHYSIOGLOVE ES WITH ECG ANALYSIS | Commwell , Ltd. | 2011-10-21 | Traditional | PDF ↗ |
| K112431 | DIGITAL ELECTROCARDIOGRAPH | Shenzhen Biocare Electronics Co., Ltd. | 2011-09-22 | Special | PDF ↗ |
| K111438 | REKA E100 | Reka Pte, Ltd. | 2011-09-12 | Abbreviated | PDF ↗ |
| K111805 | ECG SERIES ELECTROCARDIOGRAPH | Advanced Instrumentations, Inc. | 2011-08-24 | Traditional | PDF ↗ |
| K112135 | ECG-6 SERIES ELECTROCARDIOGRAPH | Advanced Instrumentations, Inc. | 2011-08-05 | Traditional | PDF ↗ |
| K110328 | ACG-8511 PORTABLE ECG MONITOR | Andon Health Co, Ltd. | 2011-07-15 | Traditional | PDF ↗ |
| K103077 | ECG PEN | Meridian Dynamics Biomedical, Inc. | 2011-07-13 | Traditional | PDF ↗ |
| K111601 | HERO | Medical Predictive Science Corp. | 2011-07-08 | Special | PDF ↗ |
| K102767 | CARDIO XP | Bionet Co., Ltd. | 2011-06-03 | Traditional | PDF ↗ |
| K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM | Ge Medical Systems Information Technologies, Inc. | 2011-05-17 | Traditional | PDF ↗ |
| K110266 | MAC 5500 HD, MAC 3500 | Ge Medical Systems Information Technologies, Inc. | 2011-04-29 | Traditional | PDF ↗ |
| K101867 | VICOR PD2I ANALYZER | Vicor Technologies, Inc. | 2011-04-14 | Traditional | PDF ↗ |
| K103427 | MOBILEECG SYSTEM | Memtec Corp. | 2011-03-24 | Traditional | PDF ↗ |
| K103640 | MIDMARK IQECG | Brentwood Medical Technology Corp. | 2011-03-22 | Traditional | PDF ↗ |
| K110065 | SPAULDING IQ ELECTROCARDIOGRAPH | Spaulding Clinical Research, LLC | 2011-03-02 | Abbreviated | PDF ↗ |
| K101876 | DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 | Shenzhen Biocare Electronics Co., Ltd. | 2011-03-01 | Traditional | PDF ↗ |
| K101569 | V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER | Taidoc Technology Corporation | 2011-03-01 | Traditional | PDF ↗ |
| K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 | Mortara Instrument, Inc. | 2011-02-18 | Abbreviated | PDF ↗ |
| K101016 | ANS SYSTEM | Caird Technology | 2011-01-28 | Traditional | PDF ↗ |
| K102854 | PC ECG | Edan Instruments, Inc. | 2010-12-03 | Special | PDF ↗ |
| K102830 | ELECTROCARDIOGRAPH | Edan Instruments, Inc. | 2010-12-02 | Special | PDF ↗ |
| K100813 | QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB | Pulse Biomedical, Inc. | 2010-07-23 | Special | PDF ↗ |
| K101403 | ELI 250 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-07-02 | Abbreviated | PDF ↗ |
| K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | Mortara Instrument, Inc. | 2010-06-18 | Abbreviated | PDF ↗ |
| K093211 | CARECENTER MD | Cardiac Science Corporation | 2010-06-03 | Traditional | PDF ↗ |
| K100127 | ELI 230 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-04-16 | Abbreviated | PDF ↗ |
| K093869 | SE-601 SERIES ELECTROCARDIOGRAPH | Edan Instruments, Inc. | 2010-04-01 | Traditional | PDF ↗ |
| K093872 | HANDHELD ECG MONITOR, MODEL MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-03-31 | Traditional | PDF ↗ |
| K093339 | ELI PC ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2010-02-19 | Abbreviated | PDF ↗ |
| K093172 | QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) | Dynacardia, Inc. | 2010-01-20 | Traditional | PDF ↗ |
| K092663 | ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2009-12-14 | Abbreviated | PDF ↗ |
| K092010 | PC ECG, MODEL SE-1010 | Edan Instruments, Inc. | 2009-10-22 | Traditional | PDF ↗ |
| K083715 | BELTBEAT WF-400 | Bonus Communicaciones Srl | 2009-09-15 | Traditional | PDF ↗ |
| K092576 | GEM HEART ONE/ONE+ | Gem-Med S.L. | 2009-09-04 | Traditional | PDF ↗ |
| K090936 | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A | Contec Medical System Co., Ltd. | 2009-08-25 | Traditional | PDF ↗ |
| K091513 | SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 | Edan Instruments, Inc. | 2009-07-24 | Traditional | PDF ↗ |
| K091397 | ECSCOPE 200 | Dyansys, Inc. | 2009-07-08 | Traditional | PDF ↗ |
| K090367 | SE-601 SERIES ELECTROCARDIOGRAPH | Edan Instruments, Inc. | 2009-06-03 | Traditional | PDF ↗ |
| K091358 | ECSCOPE 100 | Dyansys, Inc. | 2009-05-28 | Traditional | PDF ↗ |
| K090249 | MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM | Harbinger Medical, Inc. | 2009-04-03 | Special | PDF ↗ |
| K082967 | MORTARA STRESS ECHO BED | Medical Positioning, Inc. | 2009-03-26 | Special | PDF ↗ |
| K090483 | SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS | Philips Medical Systems | 2009-03-20 | Special | PDF ↗ |
| K082124 | CARDITTE MICROTEL | Et Medical Devices Spa | 2009-02-19 | Special | PDF ↗ |
| K090212 | MAC 800 RESTING ECG ANALYSIS SYSTEM | Ge Medical Syst. Information Technologies | 2009-02-19 | Special | PDF ↗ |
| K082946 | MORTARA ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2008-12-29 | Traditional | PDF ↗ |
| K082709 | VICOR PD2I ANALYZER, VERSION 2.1 | Vicor Technologies, Inc. | 2008-12-29 | Traditional | PDF ↗ |
| K082380 | VICARDIO 12B | Energy-Lab Technologies GmbH | 2008-12-03 | Traditional | PDF ↗ |
| K082013 | CLUE MEDICAL AND CLUE MEDICAL BASIC | Telovital GmbH Telemedizin | 2008-11-10 | Traditional | PDF ↗ |
| K080933 | HANDHELD ECG MONITOR, MODEL MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-09-26 | Traditional | PDF ↗ |
| K082312 | PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) | Heartscape Technologies, Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K082173 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S | Cardiac Science Corporation | 2008-08-26 | Special | PDF ↗ |
| K081437 | MAC 1600 ECG ANALYSIS SYSTEM | Ge Medical Systems Information Technologies | 2008-07-15 | Traditional | PDF ↗ |
| K081473 | HERO, VERSION 2.0 | Medical Predictive Science Corp. | 2008-06-27 | Special | PDF ↗ |
| K080999 | PAGEWRITER CARDIOGRAPH | Philips Medical Systems | 2008-05-09 | Special | PDF ↗ |
| K080884 | QHRV 1 - HEALTH ASSESSMENT SYSTEM | Medtechs, LLC | 2008-04-11 | Traditional | PDF ↗ |
| K073625 | MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM | Ge Healthcare Systems Information Technologies | 2008-01-25 | Special | PDF ↗ |
| K080036 | PORTABLE ECSCOPE 12I | Dyansys, Inc. | 2008-01-16 | Traditional | PDF ↗ |
| K072449 | CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS | Welch Allyn, Inc. | 2007-11-29 | Abbreviated | PDF ↗ |
| K071168 | THE PORTABLE ANSISCOPE | Dyansys, Inc. | 2007-08-31 | Traditional | PDF ↗ |
| K072217 | ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M | Nihon Kohden America, Inc. | 2007-08-30 | Special | PDF ↗ |
| K072353 | PORTABLE ECSCOPE | Dyansys Corp | 2007-08-30 | Traditional | PDF ↗ |
| K072060 | QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V | Nihon Kohden America, Inc. | 2007-08-17 | Special | PDF ↗ |
| K061123 | PALM ECG RECORDER, MODEL EP-201/202 | Parama-Tech Company., Ltd. | 2007-06-29 | Traditional | PDF ↗ |
| K070614 | CORSCREEN | Viasys Healthcare GmbH | 2007-05-04 | Traditional | PDF ↗ |
| K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | Inovise Medical, Inc. | 2007-04-13 | Traditional | PDF ↗ |
| K062282 | MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0 | Monebo Technologies, Inc. | 2007-03-22 | Traditional | PDF ↗ |
| K070539 | MORTARA ELI 10 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2007-03-15 | Special | PDF ↗ |
| K062894 | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 | Dailycare Biomedical, Inc. | 2007-02-08 | Traditional | PDF ↗ |
| K062677 | ELI 350 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 2006-11-15 | Special | PDF ↗ |
| K062469 | VOYAGER 12 | Del Mar Reynolds Medical, Ltd. | 2006-11-03 | Special | PDF ↗ |
| K062068 | INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 | Intelwave, LLC | 2006-10-27 | Traditional | PDF ↗ |
| K060766 | PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 | Omron Healthcare, Inc. | 2006-06-09 | Traditional | PDF ↗ |
| K052511 | CARDIOFAX CE, MODEL ECG-1500 A | Nihon Kohden America, Inc. | 2006-05-24 | Traditional | PDF ↗ |
| K050674 | PHYSIOGLOVE ES | Commwell , Ltd. | 2006-04-25 | Traditional | PDF ↗ |
Product code DPS · Class II · Cardiovascular. Data: openFDA.