DRG · Class II · 21 CFR 870.2910

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

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

192
Total
192
Cleared
127d
Avg days
1977
Since
192 devices
49–72 of 192
Cleared Nov 19, 2002
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B)
K023749
Philips Medical Systems
Cardiovascular · 11d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Jan 08, 1998
AMBULATORY X-12 TELEMETRY MODULE
K974149
Mortara Instrument, Inc.
Cardiovascular · 65d
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
Cleared Jun 26, 1986
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR
K860239
Nihon Kohden America, Inc.
Cardiovascular · 154d
Cleared May 15, 1985
QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR
K851302
Quinton, Inc.
Cardiovascular · 44d
Cleared Jan 10, 1985
MODEL 78210A TELEMETRY TRANSMITTER
K844376
Hewlett-Packard Co.
Cardiovascular · 58d
Cleared Jan 10, 1984
TELEMETRY SYS SERIES 7700 ECG
K832817
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Nov 24, 1982
LIFESCOPE II/FOUR
K823249
Nihon Kohden America, Inc.
Cardiovascular · 23d
Cleared Jun 17, 1982
EXERCISE ECG ELECTRODES, REUSABLE
K821384
Respironics, Inc.
Cardiovascular · 38d
Cleared Dec 29, 1981
TELEMETRY TRANSMITTER & RECEIVER
K813064
Honeywell, Inc.
Cardiovascular · 60d
Cleared Mar 20, 1981
DUO-TEL
K810331
General Electric Co.
Cardiovascular · 39d
Cleared Feb 12, 1981
TELEMETRY PACEMAKER MONITOR
K802357
Intermedics, Inc.
Cardiovascular · 139d
Cleared Dec 16, 1980
TECNOL TELEMETRY UNIT POUCH
K802849
Tecnol New Jersey Wound Care, Inc.
Cardiovascular · 34d
Cleared Oct 23, 1980
MULTICHANNEL TELEMETRY SYSTEM
K801944
Burdick Corp.
Cardiovascular · 70d
Cleared Oct 03, 1980
TELEMETRY TRANSMITTER, #TLT-3
K802273
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 16d
Cleared Aug 03, 1979
KWIK-AWA VEST
K791363
Medical Specialties, Inc.
Cardiovascular · 17d
Cleared Feb 23, 1979
TELEMETRY SYSTEM 315
K790144
Ge Medical Systems Information Technologies
Cardiovascular · 35d
Cleared Dec 04, 1978
TELEMETRY SYSTEM, BIOTEL 300
K781836
Spacelabs, Inc.
Cardiovascular · 35d