Ge Medical Systems Information Technologies - FDA 510(k) Cleared Devi...
136
Total
132
Cleared
0
Denied
136 devices
Cleared
May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
Cardiovascular
260d
Cleared
May 06, 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
Cardiovascular
11d
Cleared
Mar 21, 2003
MODIFICATION TO SOLAR 9500 INFORMATION MONITOR
Cardiovascular
25d
Cleared
Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
Cardiovascular
16d
Cleared
Aug 13, 2002
SENSA-CUFF, MODELS INFANT, CHILD, ADULT
Cardiovascular
15d
Cleared
Aug 01, 2002
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
Anesthesiology
27d
Cleared
Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
Cardiovascular
188d
Cleared
May 22, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
Cardiovascular
16d
Cleared
May 09, 2002
MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
Obstetrics & Gynecology
30d
Cleared
Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
Cardiovascular
203d
Cleared
Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
Cardiovascular
29d
Cleared
Nov 13, 2001
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
Obstetrics & Gynecology
90d
Cleared
Feb 02, 2000
COROMETRICS MODEL 173 FETAL MONITOR
Obstetrics & Gynecology
89d
Cleared
Nov 05, 1998
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
Anesthesiology
251d
Cleared
Mar 06, 1997
COROMETRICS MODEL 510 AND 511 MONITOR
Anesthesiology
232d
Cleared
Feb 21, 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
Obstetrics & Gynecology
86d
Cleared
Mar 05, 1996
COROMETRICS FETAL MOVEMENT DETECTION KIT
Obstetrics & Gynecology
90d
Cleared
Jul 25, 1995
MODEL 510 INFANT MONITOR
Anesthesiology
382d
Cleared
Jun 02, 1995
MODEL 511 INFANT MONITOR
Anesthesiology
394d
Cleared
Aug 15, 1994
MODEL 118 FETAL/MATERNAL MONITOR
Obstetrics & Gynecology
304d
Cleared
Mar 31, 1994
MODEL 151 FETAL MONITOR
Obstetrics & Gynecology
336d
Cleared
Apr 27, 1992
COROMETRICS MODEL 150 FETAL MONITOR
Obstetrics & Gynecology
89d
Cleared
Apr 02, 1992
ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM
Radiology
64d
Cleared
Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
Cardiovascular
323d
Cleared
Jun 10, 1991
COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD
Cardiovascular
84d
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