DXG · Class II · 21 CFR 870.1435

FDA Product Code DXG: Computer, Diagnostic, Pre-programmed, Single-function

Leading manufacturers include Edwards Lifesciences, LLC, Hewlett-Packard Co. and Transonic Systems, Inc..

177
Total
177
Cleared
130d
Avg days
1976
Since
177 devices
25–48 of 177
Cleared Jun 14, 2011
EV1000 CLINICAL PLATFORM
K110597
Edwards Lifesciences
Cardiovascular · 104d
Cleared May 17, 2011
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR
K103094
Edwards Lifesciences, LLC
Cardiovascular · 210d
Cleared Dec 07, 2010
EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
K100709
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Dec 09, 2008
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K082308
Edwards Lifesciences, LLC
Cardiovascular · 118d
Cleared Sep 08, 2008
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K080116
Transonic Systems, Inc.
Cardiovascular · 236d
Cleared Jan 03, 2008
INFINITY PICCO POD, MODEL MS16734
K073113
Draeger Medical Systems, Inc.
Cardiovascular · 59d
Cleared Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K062134
Edwards Lifesciences, LLC
Cardiovascular · 27d
Cleared Apr 25, 2006
EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER
K060660
Edwards Lifesciences, LLC
Cardiovascular · 43d
Cleared Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
K043103
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Nov 12, 2004
NICOM
K042144
Cheetah Medical, Inc.
Cardiovascular · 95d
Cleared Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
K040287
Edwards Lifesciences, LLC
Cardiovascular · 80d
Cleared Oct 15, 2003
MODIFICATION TO: HORIZON 9000WS
K032997
Mennen Medical , Ltd.
Cardiovascular · 20d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874
Abbott Laboratories
Cardiovascular · 35d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Jun 24, 1999
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
K991775
Mennen Medical, Inc.
Cardiovascular · 30d
Cleared Jan 08, 1999
LIDCO SYSTEM
K962918
Lidco, Ltd.
Cardiovascular · 925d
Cleared May 14, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3/T)
K970784
Alexander Mfg. Co.
Cardiovascular · 71d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661
Abbott Laboratories
Cardiovascular · 308d
Cleared Nov 21, 1996
TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)
K962128
Hemo Sapiens, Inc.
Cardiovascular · 171d
Cleared Mar 08, 1996
VITAL PAK
K955417
Vital Signs, Inc.
Cardiovascular · 102d
Cleared Jan 06, 1995
HORIZON 9000 WS
K940415
Mennen Medical, Inc.
Cardiovascular · 343d
Cleared Dec 15, 1994
CARDIAC OUTPUT OPTION 39
K943256
Medical Data Electronics
Cardiovascular · 162d
Cleared Nov 14, 1994
CONTINUOUS CARDIAC OUTPUT SYSTEM
K932414
Abbott Laboratories
Cardiovascular · 544d
Cleared Dec 20, 1991
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
K913358
Ppg Industries, Inc.
Cardiovascular · 144d