DRG · Class II · 21 CFR 870.2910

FDA Product Code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Leading manufacturers include Vitalconnect, Inc., Nihon Kohden America, Inc. and Philips Medical Systems.

192
Total
192
Cleared
127d
Avg days
1977
Since
192 devices
97–120 of 192
Cleared Jan 16, 2009
FORA TELEHEALTH SYSTEM
K083046
Taidoc Technology Corporation
Cardiovascular · 94d
Cleared Aug 31, 2007
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
K071564
Philips Medical Systems
Cardiovascular · 85d
Cleared Jun 29, 2007
MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A
K071058
Nihon Kohden America, Inc.
Cardiovascular · 74d
Cleared Nov 18, 2005
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS, WITH 802.11 WIRELESS LAN
K052961
Philips Medical Systems
Cardiovascular · 28d
Cleared Jun 08, 2005
REMOTE CARE MANAGEMENT SYSTEMS (RCMS)
K051470
Bl Healthcare, Inc.
Cardiovascular · 5d
Cleared May 20, 2005
THE HERMES SYSTEM
K050929
Palaistra Systems, Inc.
Cardiovascular · 36d
Cleared May 13, 2005
VITALWARE VMS
K050128
Televital, Inc.
Cardiovascular · 114d
Cleared Apr 13, 2005
TELEREHAD 2004
K050778
Scottcare
Cardiovascular · 16d
Cleared Apr 05, 2005
HEALTH BUDDY APPLIANCE
K050567
Health Hero Network, Inc.
Cardiovascular · 32d
Cleared Jul 19, 2004
RTX3320PSTN WIRELESS TELEHEALTH GATEWAY
K041816
Rtx Healthcare A/S
Cardiovascular · 13d
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749
Philips Medical Systems
Cardiovascular · 11d
Cleared Mar 01, 2000
MPT 24 AND VITAL VIEW 24
K000276
Criticare Systems, Inc.
Cardiovascular · 30d
Cleared Jan 13, 2000
AVIVA SYSTEM, MODEL SL1010
K993550
American Telecare, Inc.
Cardiovascular · 85d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Jul 15, 1998
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
K981533
American Telecare, Inc.
Cardiovascular · 77d
Cleared Jan 08, 1998
AMBULATORY X-12 TELEMETRY MODULE
K974149
Mortara Instrument, Inc.
Cardiovascular · 65d
Cleared Dec 29, 1997
DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1
K973873
American Telecare, Inc.
Cardiovascular · 80d
Cleared Dec 17, 1996
PERSONAL TELEMEDICINE MODULE
K964554
American Telecare, Inc.
Cardiovascular · 34d
Cleared Nov 22, 1995
NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER
K946175
Nihon Kohden America, Inc.
Cardiovascular · 338d
Cleared Nov 14, 1995
NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER
K945578
Nihon Kohden America, Inc.
Cardiovascular · 365d
Cleared Mar 21, 1995
SIEMENS 1481 T TRANSMITTER, ENHANCED
K945037
Siemens Medical Solutions USA, Inc.
Cardiovascular · 159d
Cleared May 07, 1991
CARDIOCAP DR-124 RECORDER
K910620
Datex Division Instrumentarium Corp.
Cardiovascular · 84d
Cleared Apr 19, 1989
CD TELEMETRY SYSTEMS
K891104
Marquette Electronics, Inc.
Cardiovascular · 48d
Cleared Dec 03, 1987
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
K873672
Novametrix Medical Systems, Inc.
Cardiovascular · 83d