Medical Device Manufacturer · US , Sugarland , TX

General Electric Medical Systems Information Techn - FDA 510(k) Clear...

33 submissions · 33 cleared · Since 1999
33
Total
33
Cleared
0
Denied
FDA 510(k) Regulatory Record - General Electric Medical Systems Information Techn Cardiovascular ✕
28 devices
1-12 of 28
Cleared Dec 03, 2002
T-WAVE ALTERMANS (TWA) ALGORITHM OPTION
K023380 · DQK
Cardiovascular · 56d
Cleared Nov 14, 2002
SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
K021470 · MWJ
Cardiovascular · 190d
Cleared Oct 01, 2002
UNITY NETWORK ID
K021454 · MWI
Cardiovascular · 148d
Cleared Aug 14, 2002
DASH 3000/4000 PATIENT MONITOR
K020290 · MHX
Cardiovascular · 198d
Cleared Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · DQK
Cardiovascular · 64d
Cleared May 24, 2002
UNITY IS PATIENT VIEWER
K020661 · MSX
Cardiovascular · 84d
Cleared May 07, 2002
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
K021325 · MHX
Cardiovascular · 11d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · MSX
Cardiovascular · 29d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467 · DSI
Cardiovascular · 194d
Cleared Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · DQK
Cardiovascular · 28d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · MHX
Cardiovascular · 87d
Cleared Apr 09, 2001
ICG MODULE
K010164 · DSB
Cardiovascular · 81d
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