DRT · Class II · 21 CFR 870.2300

FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Leading manufacturers include Hewlett-Packard Co., Litton Medical Electronics and Nihon Kohden America, Inc..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
49–72 of 341
Cleared May 16, 2001
ACTIVEECG
K010587
Active Corp.
Cardiovascular · 78d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061
A&D Engineering, Inc.
Cardiovascular · 197d
Cleared Jan 12, 2001
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
K001775
Zoe Medical, Inc.
Cardiovascular · 214d
Cleared Nov 21, 2000
MICROPAQ, MODELS 402 AND 404
K002725
Protocol Systems, Inc.
Cardiovascular · 82d
Cleared Aug 19, 1999
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
K992413
Medical Data Electronics
Cardiovascular · 30d
Cleared Aug 18, 1999
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411
Medical Data Electronics
Cardiovascular · 29d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033
Welch Allyn, Inc.
Cardiovascular · 238d
Cleared Nov 03, 1998
DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1
K981378
Datex-Engstrom, Inc.
Cardiovascular · 201d
Cleared Oct 28, 1998
MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT
K974581
Invivo Research, Inc.
Cardiovascular · 324d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178
Datascope Corp.
Cardiovascular · 232d
Cleared Jan 13, 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918
Nihon Kohden America, Inc.
Cardiovascular · 90d
Cleared Dec 09, 1997
HEART PROTECTOR (VER 1996)
K965158
N.P.N.T., Inc.
Cardiovascular · 351d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Oct 17, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016
K972789
Alexander Mfg. Co.
Cardiovascular · 84d
Cleared Feb 28, 1997
MOBILE MEDICAL MONITOR (M3(A))
K963576
Scientific Applications
Cardiovascular · 175d
Cleared Oct 17, 1996
LOG-A-RYTHM MODEL 100 AND MODEL 1001
K952790
Nian-Crae, Inc.
Cardiovascular · 486d
Cleared Aug 07, 1996
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
K960544
Nasiff Assoc., Inc.
Cardiovascular · 182d
Cleared Apr 18, 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688
Safety Tek Corp.
Cardiovascular · 429d
Cleared Oct 19, 1995
EAGLE 3000 PATIENT MONITOR
K952474
Marquette Electronics, Inc.
Cardiovascular · 142d
Cleared Sep 20, 1995
RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR
K941252
Ansar
Cardiovascular · 554d
Cleared May 12, 1995
ECG MONITOR
K944262
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared May 10, 1995
PROPAQ 200 MONITOR
K945071
Protocol Systems, Inc.
Cardiovascular · 208d
Cleared Apr 12, 1995
MERCURY
K940081
Mennen Medical, Inc.
Cardiovascular · 460d
Cleared Mar 10, 1995
PRO-SPORT HEART RATE MONITOR
K943242
Sensor Dynamics, Inc.
Cardiovascular · 247d