Panels › Cardiovascular › Product code DPS · Class 2
Electrocardiograph
Regulation 870.2340
8510(k)s in 12 months (580 all time)
4recalls in 12 months (98 all time)
89recalls that name a 510(k)
Top companies in DPS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2014 | K130921 | ALIVECOR HEART MONITOR OTC AliveCor, Inc. | DPS |
| Jan 30, 2014 | K132758 | DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Bio-Medical Equipment Co., Ltd., CN | DPS |
| Jan 23, 2014 | K133622 | MAC 2000 ECG ANALYSIS SYSTEM Wipro GE Healthcare | DPS |
| Nov 22, 2013 | K131819 | PC ECG Edan Instruments, Inc., CN | DPS |
| Nov 14, 2013 | K131262 | DIGITAL ELECTROCARDIOGRAPHS Sonoscape Company Limited, CN | DPS |
| Sep 26, 2013 | K132068 | PHILIPS DXL 12/16-LEAD ECG ALGORITHM Philips Medical Systems | DPS |
| Sep 6, 2013 | K130409 | ALIVECOR HEART MONITOR AliveCor, Inc. | DPS |
| Jul 23, 2013 | K130207 | SPACELABS HEALTHCARE CARDIOEXPRESS Spacelabs Healthcare, Ltd. | DPS |
| Jul 22, 2013 | K131572 | MICRO AMBULATORY ECG RECORDER Dimetek Digital Medical Technologies, Ltd., CN | DPS |
| Jul 3, 2013 | K131573 | CP150 ELECTROCARDIOGRAPH Welch Allyn, Inc. | DPS |
| Mar 11, 2013 | K121825 | CS-MAG II Biomagnetik-Park GmbH, DE | DPS |
| Feb 27, 2013 | K123816 | DIGITAL ELECTROCARDIOGRAPHS Shenzhen Biocare Electronics Co., Ltd., CN | DPS |
| Feb 5, 2013 | K123217 | CARDEASCREEN Cardea Associates, Inc. | DPS |
| Dec 6, 2012 | K120770 | QT GUARD PLUS ANALYSIS SYSTEM Ge Medical Systems Information Technologies | DPS |
| Nov 19, 2012 | K122356 | ALIVECOR HEART MONITOR FOR IPHONE AliveCor, Inc. | DPS |
| Oct 25, 2012 | K122712 | DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Electronics Co., Ltd., CN | DPS |
| Aug 2, 2012 | K122073 | ELI 280 ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Jul 19, 2012 | K120865 | RSCRIBE ELECTROCARDIOGRAPH Mortara Instrument, Inc. | DPS |
| Jul 19, 2012 | K112622 | HANDHELD ECG MONITOR Beijing Choice Electronic Technololgy Co., Ltd., CN | DPS |
| Jul 16, 2012 | K113306 | CARDIO 7 Bionet Co., Ltd. | DPS |
| May 17, 2012 | K121009 | HEARTCHECK ECG PEN WITH GEMS HOME Cardiocomm Solutions, Inc. | DPS |
| Apr 25, 2012 | K113485 | ELECTROCARDIOGRAPH Shenzhen Carewell Electronics Co., Ltd., CN | DPS |
| Apr 3, 2012 | K113144 | PAGEWRITER TC 20, 30, 50, 70 Philips Medical Systems | DPS |
| Mar 16, 2012 | K120188 | ELECTROCARDIOGRAPH Edan Instruments, Inc., CN | DPS |
| Jan 26, 2012 | K112959 | CALG-STR EXERCISE ECG ANALYSIS ALGORITHM Philips Health Care | DPS |
| Dec 22, 2011 | K111159 | HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME Cardiocomm Solutions, Inc. | DPS |
| Nov 17, 2011 | K113234 | MOBCARDIO SYSTEM Mobhealth Incorporation | DPS |
| Nov 2, 2011 | K102378 | VECTRAPLEXECG SYSTEM WITH VECTRAPLEXAMI Vectracor, Inc. | DPS |
| Oct 21, 2011 | K103791 | PHYSIOGLOVE ES WITH ECG ANALYSIS Commwell , Ltd., IL | DPS |
| Sep 22, 2011 | K112431 | DIGITAL ELECTROCARDIOGRAPH Shenzhen Biocare Electronics Co., Ltd., CN | DPS |
| Sep 12, 2011 | K111438 | REKA E100 Reka Pte, Ltd. | DPS |
| Aug 24, 2011 | K111805 | ECG SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. | DPS |
| Aug 5, 2011 | K112135 | ECG-6 SERIES ELECTROCARDIOGRAPH Advanced Instrumentations, Inc. | DPS |
| Jul 15, 2011 | K110328 | ACG-8511 PORTABLE ECG MONITOR Andon Health Co, Ltd., CN | DPS |
| Jul 13, 2011 | K103077 | ECG PEN Meridian Dynamics Biomedical, Inc. | DPS |
| Jul 8, 2011 | K111601 | HERO Medical Predictive Science Corp. | DPS |
| Jun 3, 2011 | K102767 | CARDIO XP Bionet Co., Ltd. | DPS |
| May 17, 2011 | K103765 | MAC 600 RESTING ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies, Inc. | DPS |
| Apr 29, 2011 | K110266 | MAC 5500 HD, MAC 3500 Ge Medical Systems Information Technologies, Inc. | DPS |
| Apr 14, 2011 | K101867 | VICOR PD2I ANALYZER Vicor Technologies, Inc. | DPS |
| Mar 24, 2011 | K103427 | MOBILEECG SYSTEM Memtec Corp. | DPS |
| Mar 22, 2011 | K103640 | MIDMARK IQECG Brentwood Medical Technology Corp. | DPS |
| Mar 2, 2011 | K110065 | SPAULDING IQ ELECTROCARDIOGRAPH Spaulding Clinical Research, LLC | DPS |
| Mar 1, 2011 | K101876 | DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010 Shenzhen Biocare Electronics Co., Ltd., CN | DPS |
| Mar 1, 2011 | K101569 | V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER Taidoc Technology Corporation, TW | DPS |
| Feb 18, 2011 | K102206 | ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10 Mortara Instrument, Inc. | DPS |
| Jan 28, 2011 | K101016 | ANS SYSTEM Caird Technology | DPS |
| Dec 3, 2010 | K102854 | PC ECG Edan Instruments, Inc., CN | DPS |
| Dec 2, 2010 | K102830 | ELECTROCARDIOGRAPH Edan Instruments, Inc., CN | DPS |
| Jul 23, 2010 | K100813 | QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB Pulse Biomedical, Inc. | DPS |
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