ClearanceBrief
Panels › Cardiovascular › Product code DRG · Class 2

Transmitters And Receivers, Physiological Signal, Radiofrequency

Regulation 870.2910

2510(k)s in 12 months (192 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in DRG

Company510(k)sRecalls
Vitalconnect, Inc.91
Honeywell Hommed60
Nihon Kohden America, Inc.51
American Telecare, Inc.50
General Devices50
Bl Healthcare, Inc.40
Health Hero Network, Inc.40
Lifesignals, Inc.40
Philips Medical Systems40
Biointellisense, Inc.21
Decided510(k)Device and applicantCode
Jan 18, 2002K013533EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
General Devices
DRG
May 31, 2001K002514CADHEALTH SYSTEM, MODEL CHP-001
Caduceus Health Care , Ltd., CA
DRG
Nov 21, 2000K002089ROSETTA-LT/ROSETTA-RX
General Devices
DRG
Mar 1, 2000K000276MPT 24 AND VITAL VIEW 24
Criticare Systems, Inc.
DRG
Jan 13, 2000K993550AVIVA SYSTEM, MODEL SL1010
American Telecare, Inc.
DRG
Dec 20, 1999K993169MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
Hewlett-Packard Co.
DRG
Jul 15, 1998K981533AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
American Telecare, Inc.
DRG
Jan 8, 1998K974149AMBULATORY X-12 TELEMETRY MODULE
Mortara Instrument, Inc.
DRG
Dec 29, 1997K973873DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
American Telecare, Inc.
DRG
Dec 17, 1996K964554PERSONAL TELEMEDICINE MODULE
American Telecare, Inc.
DRG
Nov 22, 1995K946175NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
Nihon Kohden America, Inc.
DRG
Nov 14, 1995K945578NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
Nihon Kohden America, Inc.
DRG
Apr 14, 1995K940009GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
General Devices
DRG
Mar 21, 1995K945037SIEMENS 1481 T TRANSMITTER, ENHANCED
Siemens Medical Solutions USA, Inc.
DRG
Nov 10, 1994K935839GEMSCOM SERIES 5000,
General Devices
DRG
Sep 1, 1994K934711PROPAQ ECG TELEMETRY OPTION
Protocol Systems, Inc.
DRG
Mar 4, 1992K914889GEMSCOM SERIES 3000
General Devices
DRG
May 7, 1991K910620CARDIOCAP DR-124 RECORDER
Datex Division Instrumentarium Corp., FI
DRG
Mar 1, 1991K904748TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
Transtracheal Systems
DRG
Apr 19, 1989K891104CD TELEMETRY SYSTEMS
Marquette Electronics, Inc.
DRG
Mar 7, 1988K880036BIOMA 5000
E.B.S., Inc., CA
DRG
Dec 3, 1987K873672MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
Novametrix Medical Systems, Inc.
DRG
Jun 26, 1986K860239ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
Nihon Kohden America, Inc.
DRG
May 15, 1985K851302QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
Quinton, Inc.
DRG
Apr 18, 1985K850166TELEMANOMETER
R.J. Ash, Medical Monitoring, Inc.
DRG
Jan 10, 1985K844376MODEL 78210A TELEMETRY TRANSMITTER
Hewlett-Packard Co.
DRG
Jan 10, 1984K832817TELEMETRY SYS SERIES 7700 ECG
Marquette Electronics, Inc.
DRG
Mar 9, 1983K823906TELEMETRY SYSTEM
Transkinetic Systems, Inc.
DRG
Nov 24, 1982K823249LIFESCOPE II/FOUR
Nihon Kohden America, Inc.
DRG
Jun 17, 1982K821384EXERCISE ECG ELECTRODES, REUSABLE
Respironics, Inc.
DRG
Dec 29, 1981K813064TELEMETRY TRANSMITTER & RECEIVER
Honeywell, Inc.
DRG
Mar 20, 1981K810331DUO-TEL
General Electric Co.
DRG
Feb 12, 1981K802357TELEMETRY PACEMAKER MONITOR
Intermedics, Inc.
DRG
Jan 13, 1981K8032294-CHANNEL ECG TELEMETRY MON. SYST. #3045
Cambridge Instruments, Inc.
DRG
Dec 16, 1980K802849TECNOL TELEMETRY UNIT POUCH
Tecnol New Jersey Wound Care, Inc.
DRG
Oct 23, 1980K801944MULTICHANNEL TELEMETRY SYSTEM
Burdick Corp.
DRG
Oct 3, 1980K802273TELEMETRY TRANSMITTER, #TLT-3
Bd Becton Dickinson Vacutainer Systems Preanalytic
DRG
Aug 3, 1979K791363KWIK-AWA VEST
Medical Specialties, Inc.
DRG
Mar 16, 1979K790109TELEMETRY, BIOMEDICAL
Lkc Technologies, Inc.
DRG
Feb 23, 1979K790144TELEMETRY SYSTEM 315
Ge Medical Systems Information Technologies
DRG
Dec 4, 1978K781836TELEMETRY SYSTEM, BIOTEL 300
Spacelabs, Inc.
DRG
Nov 22, 1977K772000ECG TELEMETRY SYSTEM
Mennen Greatbatch Electonics
DRG

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