Product code DRG— Cardiovascular
ANNE One
- Classification name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Total cleared
- 192
- First cleared
- Most recent
Clearances under product code DRG — page 2
101–192 of 192- K101078 — BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
- K100508 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
- K093134 — CERNER CAREAWARE IBUS
- K091696 — SAVI WIRELESS, MODEL PM500
- K091220 — HEALTHANYWHERE SYSTEM
- K092635 — ALCATEL-LUCENT TELEHEATH MANAGER
- K091430 — CARE PAL, MODEL CPW-10X
- K091021 — MODIFICATION TO MEDICOMPASS CONNECT
- K083862 — MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
- K090886 — RTX 3371
- K090801 — ELECTRONIC HOUSE CALL
- K090610 — HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM
- K081499 — HEALTH MANAGER, VERSION 1.1
- K083046 — FORA TELEHEALTH SYSTEM
- K083331 — CONFIDANT, MODEL 2.6
- K083115 — MODIFICATION TO INTEL HEALTH GUIDE, MODEL PHS6000
- K080798 — INTEL HEALTH GUIDE, MODEL: PHS6000
- K073710 — INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7
- K080091 — MODIFICATION TO:HEALTH BUDDY APPLIANCE
- K073038 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
- K072698 — CONFIDANT 2.5
- K072008 — BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER
- K071564 — MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
- K071953 — RTX3370
- K071058 — MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
- K070543 — MODIFICATION TO HEALTH BUDDY APPLIANCE
- K063612 — MODIFICATION TO HEALTH BUDDY APPLIANCE
- K063484 — PATIENT DATA HANDLER & DEVICES (PDH&D)
- K062662 — TELEMEDICINE SYSTEM MODEL VMS-01
- K062127 — MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP)
- K062215 — CONFIDANT 2.0
- K062304 — DLM112 DAYLINK MONITOR
- K061502 — MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
- K061606 — DEFIBRILLATOR CABLE TESTER, MODEL DT2200
- K061087 — GENESIS OTC MONITOR
- K061088 — SENTRY OTC MONITOR
- K052608 — TELEPHONE BASED BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM (RCMS)
- K052961 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
- K051470 — REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
- K050929 — THE HERMES SYSTEM
- K050128 — VITALWARE VMS
- K050778 — TELEREHAD 2004
- K050567 — HEALTH BUDDY APPLIANCE
- K041816 — RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
- K040663 — TELENABLE EMS SYSTEM
- K040966 — MODIFICATION TO CAREMATIX WELLNESS SYSTEM
- K030222 — NX SYSTEM
- K030795 — LIFESYNE SYSTEMS
- K022274 — CARECOMPANION PATIENT STATION & NURSE STATION
- K023749 — THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
- K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)
- K002514 — CADHEALTH SYSTEM, MODEL CHP-001
- K002089 — ROSETTA-LT/ROSETTA-RX
- K000276 — MPT 24 AND VITAL VIEW 24
- K993550 — AVIVA SYSTEM, MODEL SL1010
- K993169 — MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
- K981533 — AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
- K974149 — AMBULATORY X-12 TELEMETRY MODULE
- K973873 — DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
- K964554 — PERSONAL TELEMEDICINE MODULE
- K946175 — NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
- K945578 — NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
- K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300
- K945037 — SIEMENS 1481 T TRANSMITTER, ENHANCED
- K935839 — GEMSCOM SERIES 5000,
- K934711 — PROPAQ ECG TELEMETRY OPTION
- K914889 — GEMSCOM SERIES 3000
- K910620 — CARDIOCAP DR-124 RECORDER
- K904748 — TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100
- K891104 — CD TELEMETRY SYSTEMS
- K880036 — BIOMA 5000
- K873672 — MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
- K860239 — ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
- K851302 — QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
- K850166 — TELEMANOMETER
- K844376 — MODEL 78210A TELEMETRY TRANSMITTER
- K832817 — TELEMETRY SYS SERIES 7700 ECG
- K823906 — TELEMETRY SYSTEM
- K823249 — LIFESCOPE II/FOUR
- K821384 — EXERCISE ECG ELECTRODES, REUSABLE
- K813064 — TELEMETRY TRANSMITTER & RECEIVER
- K810331 — DUO-TEL
- K802357 — TELEMETRY PACEMAKER MONITOR
- K803229 — 4-CHANNEL ECG TELEMETRY MON. SYST. #3045
- K802849 — TECNOL TELEMETRY UNIT POUCH
- K801944 — MULTICHANNEL TELEMETRY SYSTEM
- K802273 — TELEMETRY TRANSMITTER, #TLT-3
- K791363 — KWIK-AWA VEST
- K790109 — TELEMETRY, BIOMEDICAL
- K790144 — TELEMETRY SYSTEM 315
- K781836 — TELEMETRY SYSTEM, BIOTEL 300
- K772000 — ECG TELEMETRY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.