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..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
25–48 of 341
Cleared Sep 15, 2010
ZOLL PROPAQ M
K102174
Zoll Medical Corporation, World Wide Headquarters
Cardiovascular · 44d
Cleared Apr 15, 2010
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K100745
Hoana Medical, Inc.
Cardiovascular · 30d
Cleared Oct 02, 2009
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
K092037
Hoana Medical, Inc.
Cardiovascular · 88d
Cleared Jul 24, 2009
UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
K091985
Ivy Biomedical Systems, Inc.
Cardiovascular · 22d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050
Criticare Systems, Inc.
Cardiovascular · 44d
Cleared Apr 13, 2009
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
K083534
Hoana Medical, Inc.
Cardiovascular · 136d
Cleared Feb 13, 2009
CARDIAC TRIGGER, MODEL: CTM300
K083854
Ivy Biomedical Systems, Inc.
Cardiovascular · 51d
Cleared Jan 16, 2009
PAM 3000
K082626
Wireless 2000 RF & Uwb Technologies , Ltd.
Cardiovascular · 129d
Cleared Sep 26, 2008
LIFEBED PATIENT VIGILANCE SYSTEM
K082366
Hoana Medical, Inc.
Cardiovascular · 39d
Cleared Sep 19, 2007
PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112
K063735
Presym, Inc.
Cardiovascular · 275d
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 Mar 01, 2005
TRIFIT 700
K033646
Healthfirst Corp.
Cardiovascular · 467d
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 Apr 08, 2003
ENVAN HEART RATE MONITOR
K030656
Envan, LLC
Cardiovascular · 36d
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 Jul 23, 2002
MICROPAQ, MODELS 402, 404
K021681
Welch Allyn Protocol, Inc.
Cardiovascular · 62d
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 Aug 20, 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451
Welch Allyn Protocol, Inc.
Cardiovascular · 19d