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 Ivy Biomedical Systems, Inc..

339
Total
339
Cleared
123d
Avg days
1976
Since
339 devices
25–48 of 339
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854
Ivy Biomedical Systems, Inc.
Cardiovascular · 51d
Cleared Aug 04, 2006
12 RL ALGORITHM
K060307
Ge Medical Systems Information Technologies
Cardiovascular · 178d
Cleared Feb 02, 2006
LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM
K052446
Hoana Medical, Inc.
Cardiovascular · 148d
Cleared Aug 12, 2005
506 PATIENT MONITOR
K051038
Ciriticare Systems, Inc.
Cardiovascular · 109d
Cleared Feb 03, 2005
TRANSMITTER, ZS-940PA SERIES
K043517
Nihon Kohden America, Inc.
Cardiovascular · 45d
Cleared Jan 10, 2005
MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701
K043354
Invivo Research, Inc.
Cardiovascular · 35d
Cleared Mar 03, 2004
PM-8000 PATIENT MONITOR, MODEL 8000
K032733
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Cardiovascular · 181d
Cleared Nov 04, 2002
PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
K023616
Ivy Biomedical Systems, Inc.
Cardiovascular · 6d
Cleared Aug 14, 2002
507EL VITAL SIGNS MONITOR
K022435
Criticare Systems, Inc.
Cardiovascular · 20d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144
Siemens Medical Solutions USA, Inc.
Cardiovascular · 30d
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763
Cobe Cardiovascular, Inc.
Cardiovascular · 90d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061
A&D Engineering, Inc.
Cardiovascular · 197d
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