Ge Medical Systems Information Technologies - FDA 510(k) Cleared Devi...

Cleared Jun 20, 2005

PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000

K051367 · MHX

Cardiovascular · 26d

Cleared May 19, 2005

SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

K050731 · MWJ

Cardiovascular · 59d

Cleared May 13, 2005

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

K050093 · DQK

Cardiovascular · 119d

Cleared Apr 05, 2005

MUSE CARDIOLOGY INFORMATION SYSTEM

K050614 · DQK

Cardiovascular · 26d

Cleared Nov 03, 2004

AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR)

K042642 · MHX

Cardiovascular · 37d

Cleared Aug 27, 2004

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

K042177 · DPS

Cardiovascular · 16d

Cleared Jun 04, 2004

MODIFICATION TO UNITY NETWORK ID

K040559 · MWI

Cardiovascular · 93d

Cleared Jun 03, 2004

MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K040458 · MHX

Cardiovascular · 101d

Cleared Jan 15, 2004

SOLAR 9500 INFORMATION MONITOR

K033964 · MHX

Cardiovascular · 24d

Cleared Dec 18, 2003

MODIFICATION TO UNITY NETWORK ID

K033672 · MWI

Cardiovascular · 24d

Cleared Nov 24, 2003

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

K033492 · MHX

Cardiovascular · 20d

Cleared Nov 12, 2003

MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K033304 · MHX

Cardiovascular · 29d

Cleared Nov 06, 2003

APEXPRO FH TELEMETRY SYSTEM

K033365 · MHX

Cardiovascular · 16d

Cleared Oct 30, 2003

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION

K032513 · DQK

Cardiovascular · 77d

Cleared Oct 10, 2003

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

K032577 · DQK

Cardiovascular · 50d

Cleared Sep 17, 2003

UNITY NETWORK PATIENT DATA SERVER

K032582 · MSX

Cardiovascular · 27d

Cleared Aug 15, 2003

MODIFICATION TO: APEXPRO TELEMETRY SYSTEM

K032369 · MHX

Cardiovascular · 14d

Cleared Aug 13, 2003

CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION

K032370 · DSI

Cardiovascular · 12d

Cleared Aug 05, 2003

UNITY NETWORK IS PATIENT VIEWER

K032346 · MSX

Cardiovascular · 6d

Cleared Aug 01, 2003

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

K031561 · DQK

Cardiovascular · 74d

Cleared Jul 16, 2003

DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES

K031376 · MHX

Cardiovascular · 76d

Cleared May 13, 2003

DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000

K022834 · MHX

Cardiovascular · 260d

Cleared May 06, 2003

EK-PRO ARRHYTHMIA DETECTION ALGORITHM

K031320 · MHX

Cardiovascular · 11d

Cleared Mar 21, 2003

MODIFICATION TO SOLAR 9500 INFORMATION MONITOR

K030575 · MHX

Cardiovascular · 25d

Cleared Feb 26, 2003

MODIFICATION TO DASH 3000/4000 PATIENT MONITOR

K030431 · MHX

Cardiovascular · 16d