FDA Product Code
FDA Product Code DRG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2910
510(k) Clearances — 192 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101078 | BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM | Bl Healthcare, Inc. | 2010-05-10 | Special | PDF ↗ |
| K100508 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B | Carematix, Inc. | 2010-05-05 | Special | PDF ↗ |
| K093134 | CERNER CAREAWARE IBUS | Cerner Corp. | 2009-11-27 | Traditional | PDF ↗ |
| K091696 | SAVI WIRELESS, MODEL PM500 | Medicomp, Inc. | 2009-10-26 | Special | PDF ↗ |
| K091220 | HEALTHANYWHERE SYSTEM | Healthanywhere, an Igeacare System Company | 2009-09-21 | Traditional | PDF ↗ |
| K092635 | ALCATEL-LUCENT TELEHEATH MANAGER | Alcatel-Lucent Canada, Inc. | 2009-09-10 | Traditional | PDF ↗ |
| K091430 | CARE PAL, MODEL CPW-10X | Digio2 International Co., Ltd. | 2009-08-21 | Traditional | PDF ↗ |
| K091021 | MODIFICATION TO MEDICOMPASS CONNECT | Imetrikus, Inc. | 2009-07-15 | Traditional | PDF ↗ |
| K083862 | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM | Medapps, Inc. | 2009-06-05 | Traditional | PDF ↗ |
| K090886 | RTX 3371 | Tunstall Healthcare | 2009-04-15 | Traditional | PDF ↗ |
| K090801 | ELECTRONIC HOUSE CALL | Express MD Solutions, LLC | 2009-04-08 | Traditional | PDF ↗ |
| K090610 | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM | Hospira, Inc. | 2009-03-13 | Traditional | PDF ↗ |
| K081499 | HEALTH MANAGER, VERSION 1.1 | Biocomfort Diagnostics GmbH & Co. KG | 2009-01-16 | Traditional | PDF ↗ |
| K083046 | FORA TELEHEALTH SYSTEM | Taidoc Technology Corporation | 2009-01-16 | Traditional | PDF ↗ |
| K083331 | CONFIDANT, MODEL 2.6 | Confidant, Inc. | 2009-01-09 | Special | PDF ↗ |
| K083115 | MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000 | Intel Corp. | 2008-11-26 | Special | PDF ↗ |
| K080798 | INTEL HEALTH GUIDE, MODEL: PHS6000 | Intel Corp. | 2008-06-27 | Abbreviated | PDF ↗ |
| K073710 | INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 | Intouch Technologies | 2008-04-11 | Traditional | PDF ↗ |
| K080091 | MODIFICATION TO:HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2008-02-05 | Special | PDF ↗ |
| K073038 | CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B | Carematix, Inc. | 2008-01-11 | Special | PDF ↗ |
| K072698 | CONFIDANT 2.5 | Confidant, Inc. | 2007-11-16 | Traditional | PDF ↗ |
| K072008 | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER | Braemar, Inc. | 2007-10-03 | Traditional | PDF ↗ |
| K071564 | MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921 | Philips Medical Systems | 2007-08-31 | Traditional | PDF ↗ |
| K071953 | RTX3370 | Rtx Healthcare A/S | 2007-08-08 | Special | PDF ↗ |
| K071058 | MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A | Nihon Kohden America, Inc. | 2007-06-29 | Special | PDF ↗ |
| K070543 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2007-03-28 | Special | PDF ↗ |
| K063612 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2006-12-29 | Special | PDF ↗ |
| K063484 | PATIENT DATA HANDLER & DEVICES (PDH&D) | Intermed Advisors, Inc. | 2006-12-22 | Traditional | PDF ↗ |
| K062662 | TELEMEDICINE SYSTEM MODEL VMS-01 | Medic4all (Israel) , Ltd. | 2006-11-21 | Traditional | PDF ↗ |
| K062127 | MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) | Medic4all (Israel) , Ltd. | 2006-11-08 | Traditional | PDF ↗ |
| K062215 | CONFIDANT 2.0 | Confidant, Inc. | 2006-10-16 | Special | PDF ↗ |
| K062304 | DLM112 DAYLINK MONITOR | Rtx Healthcare A/S | 2006-09-29 | Traditional | PDF ↗ |
| K061502 | MEDIC4ALL TELEMEDICINE SYSTEM VMS-01 | Medic4all (Israel) , Ltd. | 2006-09-15 | Traditional | PDF ↗ |
| K061606 | DEFIBRILLATOR CABLE TESTER, MODEL DT2200 | Medical Devices/Padpro, Inc. | 2006-06-21 | Traditional | PDF ↗ |
| K061087 | GENESIS OTC MONITOR | Honeywell Hommed, LLC | 2006-06-09 | Traditional | PDF ↗ |
| K061088 | SENTRY OTC MONITOR | Honeywell Hommed, LLC | 2006-06-09 | Traditional | PDF ↗ |
| K052608 | TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS) | Bl Healthcare, Inc. | 2006-02-01 | Traditional | PDF ↗ |
| K052961 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN | Philips Medical Systems | 2005-11-18 | Special | PDF ↗ |
| K051470 | REMOTE CARE MANAGEMENT SYSTEMS (RCMS) | Bl Healthcare, Inc. | 2005-06-08 | Traditional | PDF ↗ |
| K050929 | THE HERMES SYSTEM | Palaistra Systems, Inc. | 2005-05-20 | Traditional | PDF ↗ |
| K050128 | VITALWARE VMS | Televital, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K050778 | TELEREHAD 2004 | Scottcare | 2005-04-13 | Traditional | PDF ↗ |
| K050567 | HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2005-04-05 | Special | PDF ↗ |
| K041816 | RTX3320PSTN WIRELESS TELEHEALTH GATEWAY | Rtx Healthcare A/S | 2004-07-19 | Traditional | PDF ↗ |
| K040663 | TELENABLE EMS SYSTEM | Molex, Inc. | 2004-06-30 | Traditional | PDF ↗ |
| K040966 | MODIFICATION TO CAREMATIX WELLNESS SYSTEM | Carematix, Inc. | 2004-06-02 | Traditional | PDF ↗ |
| K030222 | NX SYSTEM | American Telecare, Inc. | 2003-08-19 | Traditional | PDF ↗ |
| K030795 | LIFESYNE SYSTEMS | Gmp/Companies, Inc. | 2003-08-05 | Traditional | PDF ↗ |
| K022274 | CARECOMPANION PATIENT STATION & NURSE STATION | Neptec Design Group, Ltd. | 2003-05-29 | Traditional | PDF ↗ |
| K023749 | THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) | Philips Medical Systems | 2002-11-19 | Special | PDF ↗ |
| K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | General Devices | 2002-01-18 | Traditional | PDF ↗ |
| K002514 | CADHEALTH SYSTEM, MODEL CHP-001 | Caduceus Health Care , Ltd. | 2001-05-31 | Traditional | PDF ↗ |
| K002089 | ROSETTA-LT/ROSETTA-RX | General Devices | 2000-11-21 | Traditional | PDF ↗ |
| K000276 | MPT 24 AND VITAL VIEW 24 | Criticare Systems, Inc. | 2000-03-01 | Special | PDF ↗ |
| K993550 | AVIVA SYSTEM, MODEL SL1010 | American Telecare, Inc. | 2000-01-13 | Traditional | PDF ↗ |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | Hewlett-Packard Co. | 1999-12-20 | Traditional | PDF ↗ |
| K981533 | AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 | American Telecare, Inc. | 1998-07-15 | Traditional | PDF ↗ |
| K974149 | AMBULATORY X-12 TELEMETRY MODULE | Mortara Instrument, Inc. | 1998-01-08 | Traditional | PDF ↗ |
| K973873 | DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 | American Telecare, Inc. | 1997-12-29 | Traditional | PDF ↗ |
| K964554 | PERSONAL TELEMEDICINE MODULE | American Telecare, Inc. | 1996-12-17 | Traditional | PDF ↗ |
| K946175 | NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER | Nihon Kohden America, Inc. | 1995-11-22 | Traditional | PDF ↗ |
| K945578 | NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER | Nihon Kohden America, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | General Devices | 1995-04-14 | Traditional | PDF ↗ |
| K945037 | SIEMENS 1481 T TRANSMITTER, ENHANCED | Siemens Medical Solutions USA, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K935839 | GEMSCOM SERIES 5000, | General Devices | 1994-11-10 | Traditional | PDF ↗ |
| K934711 | PROPAQ ECG TELEMETRY OPTION | Protocol Systems, Inc. | 1994-09-01 | Traditional | PDF ↗ |
| K914889 | GEMSCOM SERIES 3000 | General Devices | 1992-03-04 | Traditional | PDF ↗ |
| K910620 | CARDIOCAP DR-124 RECORDER | Datex Division Instrumentarium Corp. | 1991-05-07 | Traditional | PDF ↗ |
| K904748 | TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100 | Transtracheal Systems | 1991-03-01 | Traditional | PDF ↗ |
| K891104 | CD TELEMETRY SYSTEMS | Marquette Electronics, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K880036 | BIOMA 5000 | E.B.S., Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K873672 | MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR | Novametrix Medical Systems, Inc. | 1987-12-03 | Traditional | PDF ↗ |
| K860239 | ORG-7201 MULTIPARAMETER TELEMETRY MONITOR | Nihon Kohden America, Inc. | 1986-06-26 | Traditional | PDF ↗ |
| K851302 | QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR | Quinton, Inc. | 1985-05-15 | Traditional | PDF ↗ |
| K850166 | TELEMANOMETER | R.J. Ash, Medical Monitoring, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844376 | MODEL 78210A TELEMETRY TRANSMITTER | Hewlett-Packard Co. | 1985-01-10 | Traditional | PDF ↗ |
| K832817 | TELEMETRY SYS SERIES 7700 ECG | Marquette Electronics, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K823906 | TELEMETRY SYSTEM | Transkinetic Systems, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823249 | LIFESCOPE II/FOUR | Nihon Kohden America, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K821384 | EXERCISE ECG ELECTRODES, REUSABLE | Respironics, Inc. | 1982-06-17 | Traditional | PDF ↗ |
| K813064 | TELEMETRY TRANSMITTER & RECEIVER | Honeywell, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K810331 | DUO-TEL | General Electric Co. | 1981-03-20 | Traditional | PDF ↗ |
| K802357 | TELEMETRY PACEMAKER MONITOR | Intermedics, Inc. | 1981-02-12 | Traditional | PDF ↗ |
| K803229 | 4-CHANNEL ECG TELEMETRY MON. SYST. #3045 | Cambridge Instruments, Inc. | 1981-01-13 | Traditional | PDF ↗ |
| K802849 | TECNOL TELEMETRY UNIT POUCH | Tecnol New Jersey Wound Care, Inc. | 1980-12-16 | Traditional | PDF ↗ |
| K801944 | MULTICHANNEL TELEMETRY SYSTEM | Burdick Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K802273 | TELEMETRY TRANSMITTER, #TLT-3 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1980-10-03 | Traditional | PDF ↗ |
| K791363 | KWIK-AWA VEST | Medical Specialties, Inc. | 1979-08-03 | Traditional | PDF ↗ |
| K790109 | TELEMETRY, BIOMEDICAL | Lkc Technologies, Inc. | 1979-03-16 | Traditional | PDF ↗ |
| K790144 | TELEMETRY SYSTEM 315 | Ge Medical Systems Information Technologies | 1979-02-23 | Traditional | PDF ↗ |
| K781836 | TELEMETRY SYSTEM, BIOTEL 300 | Spacelabs, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K772000 | ECG TELEMETRY SYSTEM | Mennen Greatbatch Electonics | 1977-11-22 | Traditional | PDF ↗ |
Product code DRG · Class II · Cardiovascular. Data: openFDA.