General Electric Medical Systems Information Techn - FDA 510(k) Clear...
Recent clearances: T-WAVE ALTERMANS (TWA) ALGORITHM OPTION, SEER LIGHT COMPACT DIGITAL HOLTER RECORDER, ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS
33
Total
33
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Electric Medical Systems Information Techn Cardiovascular ✕
28 devices
Cleared
Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
Cardiovascular
56d
Cleared
Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
Cardiovascular
190d
Cleared
Oct 01, 2002
UNITY NETWORK ID
Cardiovascular
148d
Cleared
Aug 14, 2002
DASH 3000/4000 PATIENT MONITOR
Cardiovascular
198d
Cleared
Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
Cardiovascular
64d
Cleared
May 24, 2002
UNITY IS PATIENT VIEWER
Cardiovascular
84d
Cleared
May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
Cardiovascular
11d
Cleared
Mar 20, 2002
PATIENTNET MONITORING SYSTEM
Cardiovascular
29d
Cleared
Feb 11, 2002
SOLAR 8000M SYSTEM
Cardiovascular
194d
Cleared
Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
Cardiovascular
28d
Cleared
Jun 29, 2001
TRAM 2001 MODULE
Cardiovascular
87d
Cleared
Apr 09, 2001
ICG MODULE
Cardiovascular
81d