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192 FDA 510(k) clearances · Product code

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RecordFirmDate
BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (K101078)Bl Healthcare, Inc.2010-05-10
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K100508)Carematix, Inc.2010-05-05
CERNER CAREAWARE IBUS (K093134)Cerner Corp.2009-11-27
SAVI WIRELESS, MODEL PM500 (K091696)Medicomp, Inc.2009-10-26
HEALTHANYWHERE SYSTEM (K091220)Healthanywhere, an Igeacare System Company2009-09-21
ALCATEL-LUCENT TELEHEATH MANAGER (K092635)Alcatel-Lucent Canada, Inc.2009-09-10
CARE PAL, MODEL CPW-10X (K091430)Digio2 International Co., Ltd.2009-08-21
MODIFICATION TO MEDICOMPASS CONNECT (K091021)Imetrikus, Inc.2009-07-15
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM (K083862)Medapps, Inc.2009-06-05
RTX 3371 (K090886)Tunstall Healthcare2009-04-15
ELECTRONIC HOUSE CALL (K090801)Express MD Solutions, LLC2009-04-08
HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM (K090610)Hospira, Inc.2009-03-13
HEALTH MANAGER, VERSION 1.1 (K081499)Biocomfort Diagnostics GmbH & Co. KG2009-01-16
FORA TELEHEALTH SYSTEM (K083046)Taidoc Technology Corporation2009-01-16
CONFIDANT, MODEL 2.6 (K083331)Confidant, Inc.2009-01-09
MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 (K083115)Intel Corp.2008-11-26
INTEL HEALTH GUIDE, MODEL: PHS6000 (K080798)Intel Corp.2008-06-27
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 (K073710)Intouch Technologies2008-04-11
MODIFICATION TO:HEALTH BUDDY APPLIANCE (K080091)Health Hero Network, Inc.2008-02-05
CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B (K073038)Carematix, Inc.2008-01-11
CONFIDANT 2.5 (K072698)Confidant, Inc.2007-11-16
BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER (K072008)Braemar, Inc.2007-10-03
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 (K071564)Philips Medical Systems2007-08-31
RTX3370 (K071953)Rtx Healthcare A/S2007-08-08
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A (K071058)Nihon Kohden America, Inc.2007-06-29
MODIFICATION TO HEALTH BUDDY APPLIANCE (K070543)Health Hero Network, Inc.2007-03-28
MODIFICATION TO HEALTH BUDDY APPLIANCE (K063612)Health Hero Network, Inc.2006-12-29
PATIENT DATA HANDLER & DEVICES (PDH&D) (K063484)Intermed Advisors, Inc.2006-12-22
TELEMEDICINE SYSTEM MODEL VMS-01 (K062662)Medic4all (Israel) , Ltd.2006-11-21
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) (K062127)Medic4all (Israel) , Ltd.2006-11-08
CONFIDANT 2.0 (K062215)Confidant, Inc.2006-10-16
DLM112 DAYLINK MONITOR (K062304)Rtx Healthcare A/S2006-09-29
MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 (K061502)Medic4all (Israel) , Ltd.2006-09-15
DEFIBRILLATOR CABLE TESTER, MODEL DT2200 (K061606)Medical Devices/Padpro, Inc.2006-06-21
SENTRY OTC MONITOR (K061088)Honeywell Hommed, LLC2006-06-09
GENESIS OTC MONITOR (K061087)Honeywell Hommed, LLC2006-06-09
TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) (K052608)Bl Healthcare, Inc.2006-02-01
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN (K052961)Philips Medical Systems2005-11-18
REMOTE CARE MANAGEMENT SYSTEMS (RCMS) (K051470)Bl Healthcare, Inc.2005-06-08
THE HERMES SYSTEM (K050929)Palaistra Systems, Inc.2005-05-20
VITALWARE VMS (K050128)Televital, Inc.2005-05-13
TELEREHAD 2004 (K050778)Scottcare2005-04-13
HEALTH BUDDY APPLIANCE (K050567)Health Hero Network, Inc.2005-04-05
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY (K041816)Rtx Healthcare A/S2004-07-19
TELENABLE EMS SYSTEM (K040663)Molex, Inc.2004-06-30
MODIFICATION TO CAREMATIX WELLNESS SYSTEM (K040966)Carematix, Inc.2004-06-02
NX SYSTEM (K030222)American Telecare, Inc.2003-08-19
LIFESYNE SYSTEMS (K030795)Gmp/Companies, Inc.2003-08-05
CARECOMPANION PATIENT STATION & NURSE STATION (K022274)Neptec Design Group, Ltd.2003-05-29
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) (K023749)Philips Medical Systems2002-11-19
EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (K013533)General Devices2002-01-18
CADHEALTH SYSTEM, MODEL CHP-001 (K002514)Caduceus Health Care , Ltd.2001-05-31
ROSETTA-LT/ROSETTA-RX (K002089)General Devices2000-11-21
MPT 24 AND VITAL VIEW 24 (K000276)Criticare Systems, Inc.2000-03-01
AVIVA SYSTEM, MODEL SL1010 (K993550)American Telecare, Inc.2000-01-13
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A (K993169)Hewlett-Packard Co.1999-12-20
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 (K981533)American Telecare, Inc.1998-07-15
AMBULATORY X-12 TELEMETRY MODULE (K974149)Mortara Instrument, Inc.1998-01-08
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 (K973873)American Telecare, Inc.1997-12-29
PERSONAL TELEMEDICINE MODULE (K964554)American Telecare, Inc.1996-12-17
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER (K946175)Nihon Kohden America, Inc.1995-11-22
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER (K945578)Nihon Kohden America, Inc.1995-11-14
GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (K940009)General Devices1995-04-14
SIEMENS 1481 T TRANSMITTER, ENHANCED (K945037)Siemens Medical Solutions USA, Inc.1995-03-21
GEMSCOM SERIES 5000, (K935839)General Devices1994-11-10
PROPAQ ECG TELEMETRY OPTION (K934711)Protocol Systems, Inc.1994-09-01
GEMSCOM SERIES 3000 (K914889)General Devices1992-03-04
CARDIOCAP DR-124 RECORDER (K910620)Datex Division Instrumentarium Corp.1991-05-07
TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 (K904748)Transtracheal Systems1991-03-01
CD TELEMETRY SYSTEMS (K891104)Marquette Electronics, Inc.1989-04-19
BIOMA 5000 (K880036)E.B.S., Inc.1988-03-07
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR (K873672)Novametrix Medical Systems, Inc.1987-12-03
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR (K860239)Nihon Kohden America, Inc.1986-06-26
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR (K851302)Quinton, Inc.1985-05-15
TELEMANOMETER (K850166)R.J. Ash, Medical Monitoring, Inc.1985-04-18
MODEL 78210A TELEMETRY TRANSMITTER (K844376)Hewlett-Packard Co.1985-01-10
TELEMETRY SYS SERIES 7700 ECG (K832817)Marquette Electronics, Inc.1984-01-10
TELEMETRY SYSTEM (K823906)Transkinetic Systems, Inc.1983-03-09
LIFESCOPE II/FOUR (K823249)Nihon Kohden America, Inc.1982-11-24
EXERCISE ECG ELECTRODES, REUSABLE (K821384)Respironics, Inc.1982-06-17
TELEMETRY TRANSMITTER & RECEIVER (K813064)Honeywell, Inc.1981-12-29
DUO-TEL (K810331)General Electric Co.1981-03-20
TELEMETRY PACEMAKER MONITOR (K802357)Intermedics, Inc.1981-02-12
4-CHANNEL ECG TELEMETRY MON. SYST. #3045 (K803229)Cambridge Instruments, Inc.1981-01-13
TECNOL TELEMETRY UNIT POUCH (K802849)Tecnol New Jersey Wound Care, Inc.1980-12-16
MULTICHANNEL TELEMETRY SYSTEM (K801944)Burdick Corp.1980-10-23
TELEMETRY TRANSMITTER, #TLT-3 (K802273)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-03
KWIK-AWA VEST (K791363)Medical Specialties, Inc.1979-08-03
TELEMETRY, BIOMEDICAL (K790109)Lkc Technologies, Inc.1979-03-16
TELEMETRY SYSTEM 315 (K790144)Ge Medical Systems Information Technologies1979-02-23
TELEMETRY SYSTEM, BIOTEL 300 (K781836)Spacelabs, Inc.1978-12-04
ECG TELEMETRY SYSTEM (K772000)Mennen Greatbatch Electonics1977-11-22
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