Ge Medical Systems Information Technologies - FDA 510(k) Cleared Devi...
136
Total
132
Cleared
0
Denied
136 devices
Cleared
Jun 21, 2005
MODEL 250 SERIES MATERNAL/FETAL MONITOR
Obstetrics & Gynecology
106d
Cleared
Jun 20, 2005
PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000
Cardiovascular
26d
Cleared
May 19, 2005
SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
Cardiovascular
59d
Cleared
May 13, 2005
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
Cardiovascular
119d
Cleared
Apr 05, 2005
MUSE CARDIOLOGY INFORMATION SYSTEM
Cardiovascular
26d
Cleared
Jan 21, 2005
CENTRICITY PACS SYSTEM
Radiology
39d
Cleared
Nov 03, 2004
AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)
Cardiovascular
37d
Cleared
Oct 01, 2004
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL...
Radiology
14d
Cleared
Aug 27, 2004
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Cardiovascular
16d
Cleared
Jun 04, 2004
MODIFICATION TO UNITY NETWORK ID
Cardiovascular
93d
Cleared
Jun 03, 2004
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
Cardiovascular
101d
Cleared
Jan 15, 2004
SOLAR 9500 INFORMATION MONITOR
Cardiovascular
24d
Cleared
Dec 18, 2003
MODIFICATION TO UNITY NETWORK ID
Cardiovascular
24d
Cleared
Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
Cardiovascular
20d
Cleared
Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
Cardiovascular
29d
Cleared
Nov 06, 2003
APEXPRO FH TELEMETRY SYSTEM
Cardiovascular
16d
Cleared
Oct 30, 2003
T-WAVE ALTERNANS (TWA) ALGORITHM OPTION
Cardiovascular
77d
Cleared
Oct 10, 2003
MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
Cardiovascular
50d
Cleared
Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
Cardiovascular
27d
Cleared
Aug 21, 2003
MODEL 120 SERIES MATERNAL/FETAL MONITOR
Obstetrics & Gynecology
30d
Cleared
Aug 15, 2003
MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
Cardiovascular
14d
Cleared
Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
Cardiovascular
12d
Cleared
Aug 05, 2003
UNITY NETWORK IS PATIENT VIEWER
Cardiovascular
6d
Cleared
Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
Cardiovascular
74d
Cleared
Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
Cardiovascular
76d
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