DXG · Class II · 21 CFR 870.1435

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

Leading manufacturers include Edwards Lifesciences, LLC, Lidco, Ltd. and Hewlett-Packard Co..

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 Jul 02, 2010
CHEETAH NICOM SYSTEM
K101487
Cheetah Medical, Inc.
Cardiovascular · 35d
Cleared Jun 18, 2010
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
K091786
Pulsion Medical Systems AG
Cardiovascular · 366d
Cleared May 12, 2010
NAVIGATOR CLINICAL GUIDENCE SYSTEM
K092219
Applied Physiology Pty , Ltd.
Cardiovascular · 294d
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 Jul 22, 2008
CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM
K081776
Omega Critical Care Limited
Cardiovascular · 29d
Cleared Jan 18, 2008
NICOM ELECTRODES
K071631
Cheetah Medical, Inc.
Cardiovascular · 218d
Cleared Jan 03, 2008
INFINITY PICCO POD, MODEL MS16734
K073113
Draeger Medical Systems, Inc.
Cardiovascular · 59d
Cleared Oct 18, 2007
PULSION PICCO-2, MODEL 8500
K072735
Pulsion Medical Systems AG
Cardiovascular · 21d
Cleared Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K062134
Edwards Lifesciences, LLC
Cardiovascular · 27d
Cleared Jul 25, 2006
PULSION PICCO PLUS, MODEL 8100
K060898
Pulsion Medical Systems AG
Cardiovascular · 113d
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 Jan 09, 2003
LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
K023960
Lidco, Ltd.
Cardiovascular · 41d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874
Abbott Laboratories
Cardiovascular · 35d
Cleared Jun 14, 2001
PULSECO HEMODYNAMIC MONITOR CM71
K010049
Lidco, Ltd.
Cardiovascular · 160d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Jun 13, 2000
PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
K001762
Pulsion Medical Systems, Inc.
Cardiovascular · 4d