Panels › Cardiovascular › Product code DSH · Class 2
Recorder, Magnetic Tape, Medical
Regulation 870.2800
3510(k)s in 12 months (195 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DSH
| Company | 510(k)s | Recalls |
|---|---|---|
| Del Mar Avionics | 15 | 0 |
| Bardy Diagnostics, Inc. | 7 | 0 |
| iRhythm Technologies, Inc. | 6 | 0 |
| Oxford Medilog, Inc. | 6 | 0 |
| Cardiocomm Solutions, Inc. | 4 | 0 |
| Cardionostics, Inc. | 4 | 0 |
| Reynolds Medical , Ltd. | 4 | 0 |
| Vasomedical, Inc. | 4 | 0 |
| Aequitron Medical, Inc. | 3 | 0 |
| American Edwards Laboratories | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 9, 2010 | K101022 | PULMOTRACK 5050 WHOLTER, MODEL 5050 Karmelsonix, IL | DSH |
| Apr 2, 2010 | K092785 | COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 Vasomedical, Inc. | DSH |
| Jun 10, 2009 | K091505 | COR12+ Viasys Healthcare GmbH, DE | DSH |
| May 8, 2009 | K090363 | ZIO PATCH, MODEL Z100 iRhythm Technologies, Inc. | DSH |
| Apr 1, 2009 | K083820 | VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C Vasomedical, Inc. | DSH |
| Jan 10, 2008 | K073152 | PC-180 / PRINCE 180 EASY ECG MONITOR Shenzhen Creative Industry Co., Ltd., CN | DSH |
| Apr 6, 2007 | K070818 | MEDILOGAR4, MEDILOGAR12 Tom Medical Entwicklungs GmbH, AT | DSH |
| Aug 16, 2006 | K062007 | DMS 300-7 Diagnostic Monitoring Software | DSH |
| Aug 24, 2005 | K050896 | H12+ HOLTER RECORDER Mortara Instrument, Inc. | DSH |
| Oct 31, 2003 | K033037 | MODIFICATION TO GLOBALCARDIO Cardiocomm Solutions, Inc., CA | DSH |
| Jul 22, 2003 | K032103 | PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A Philips Medical Systems | DSH |
| Oct 24, 2002 | K022540 | CARDIO ID+(RZ153+) Rozinn Electronics, Inc. | DSH |
| Sep 27, 2002 | K022297 | GLOBAL ECG MANAGEMENT SYSTEM (GEMS) Cardiocomm Solutions, Inc., CA | DSH |
| Apr 5, 2002 | K020825 | KING OF HEARTS EXPRESS + AF MONITOR Card Guard Scientific Survival , Ltd. | DSH |
| Jan 31, 2002 | K013354 | GLOBALCARDIO Cardiocomm Solutions, Inc., CA | DSH |
| Jan 25, 2001 | K004007 | DR180+OXY North East Monitoring, Inc. | DSH |
| Apr 19, 2000 | K001025 | LIFECARD CF COMPACT RECORDER Reynolds Medical , Ltd. | DSH |
| Jun 11, 1999 | K982448 | CARDIOLIGHT Capintec, Inc. | DSH |
| Feb 9, 1999 | K990027 | OMNICORDER, MODEL 464 Del Mar Avionics | DSH |
| Jan 27, 1999 | K982384 | MERCATOR Harley Street Software , Ltd., CA | DSH |
| Aug 25, 1998 | K973735 | MICROVIT MT-100 Schiller America, Inc. | DSH |
| Feb 19, 1998 | K974420 | M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION Hewlett-Packard Co. | DSH |
| Jan 29, 1998 | K971670 | 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER Galix Biomedical Instrumentation, Inc. | DSH |
| Aug 20, 1997 | K970298 | DM-400 HOLTER ECG CASSETTE RECORDER Diagnostic Monitoring | DSH |
| Jul 28, 1997 | K971604 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP Alexander Mfg. Co. | DSH |
| May 5, 1997 | K970902 | MEDILOG FD4 Oxford Instruments Medical Systems | DSH |
| Mar 13, 1997 | K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) Del Mar Avionics | DSH |
| Mar 7, 1997 | K944180 | MODEL 700 Memtec Corp. | DSH |
| Jul 31, 1996 | K960925 | NORTHEAST MONITORING DR180 North East Monitoring, Inc. | DSH |
| Oct 12, 1995 | K950854 | VITALOGRAPH 2110 SOFTWARE INTERFACE Vitalograph , Ltd. | DSH |
| Aug 17, 1995 | K950020 | HOLTER PACERCORDER(R) Del Mar Avionics | DSH |
| Jul 14, 1995 | K951605 | SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM Spacelabs, Inc. | DSH |
| Jun 7, 1995 | K943862 | SONICAID MODEL MR-63 AMBULATORY ECG RECORDER Oxford Instruments Medical Systems | DSH |
| May 10, 1995 | K942653 | HOLTER SSR DIGICORDER(TM) Del Mar Avionics | DSH |
| Apr 12, 1995 | K945130 | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER Braemar Corp. | DSH |
| Jan 24, 1995 | K942781 | DIGITAL HOLTER RECORDER Agilent Technologies | DSH |
| Jan 18, 1995 | K942862 | HEARTPRINT Medata, Inc. | DSH |
| Oct 20, 1994 | K943278 | TRACKER 2/TRACKER 3 HOLTER RECORDER Reynolds Medical , Ltd., GB | DSH |
| Aug 5, 1994 | K942438 | ALTAIR 6100 CASSETTE RECORDER Burdick, Inc. | DSH |
| Jan 13, 1994 | K923664 | SCOLE 300 ECG RECORDER Scole Engineering Co. | DSH |
| Dec 3, 1993 | K934660 | R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211 R & D Batteries, Inc. | DSH |
| Nov 1, 1993 | K930894 | MULTITRAK-PLUS Zymed Medical Instrumentation | DSH |
| Sep 9, 1993 | K932929 | HRV 4000EM All-Tronics Medical Systems | DSH |
| Apr 6, 1992 | K920572 | UNISCAN 24 ECG ROCORDER Uniscan , Ltd. | DSH |
| Mar 30, 1992 | K921068 | GIKTER ECG CASSETTE TAPE RECORDER MODEL XR 300 Datrix | DSH |
| Oct 16, 1991 | K913600 | WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM Ralin Laboratories, Inc. | DSH |
| Oct 16, 1991 | K910884 | CARD GUARD, MODELS CG-6000 & CG-7000 Card Guard Scientific Survival , Ltd. | DSH |
| Oct 4, 1991 | K913038 | SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION Spacelabs, Inc. | DSH |
| Sep 20, 1991 | K904177 | GALIX MA-6C HOLTER CASSETTE RECORDER Galix Instrumentacion Biomedica, AR | DSH |
| Sep 20, 1991 | K904176 | GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER Galix Instrumentacion Biomedica, AR | DSH |
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