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
49–72 of 177
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 Mar 01, 1995
EK-VIEW(TM) ECG MANAGEMENT SYSTEM
K946115
Apcot Medical Systems
Cardiovascular · 76d
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 08, 1992
IQ SYSTEM
K922218
Renaissance Technology, Inc.
Cardiovascular · 210d
Cleared Dec 20, 1991
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
K913358
Ppg Industries, Inc.
Cardiovascular · 144d
Cleared Feb 25, 1991
INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUT
K902628
Biometric Research Institute, Inc.
Cardiovascular · 257d
Cleared Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
K896930
Baxter Healthcare Corp
Cardiovascular · 204d
Cleared Jun 12, 1990
SORBA MODEL CIC-1000 W/NEW ELECTRODES
K901926
Sorba Medical Systems, Inc.
Cardiovascular · 43d
Cleared Mar 14, 1990
SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH
K895017
Sorba Medical Systems, Inc.
Cardiovascular · 218d
Cleared Mar 13, 1990
NOVA MICROSONICS DATAVUE ECHO ANALYSIS SYSTEM
K897004
Advanced Technology Laboratories, Inc.
Cardiovascular · 85d
Cleared Jan 26, 1990
SFA MODULE
K896528
Life Sciences Manufacturing, Inc.
Cardiovascular · 71d
Cleared Aug 03, 1989
SENSOCOR TM R-TEST 24OXL
K894234
Sensocor
Cardiovascular · 44d
Cleared Jun 20, 1989
CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
K893392
Baxter Healthcare Corp
Cardiovascular · 50d
Cleared Apr 25, 1989
TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA
K884122
S & W Medico Teknik
Cardiovascular · 207d
Cleared Feb 02, 1989
PACH-PEN CALCULATOR
K884619
Oculab, Inc.
Cardiovascular · 90d
Cleared Nov 03, 1988
PREDICTOR II SIGNAL AVERAGING ECG
K883855
Corazonix Corp.
Cardiovascular · 51d
Cleared Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
K880301
Datascope Corp.
Cardiovascular · 207d