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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K063840
Device Name XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION
Applicant
WITT BIOMEDICAL CORP
305 NORTH DR.
MELBOURNE,  FL  32934
Applicant Contact JAMES LUKER
Correspondent
WITT BIOMEDICAL CORP
305 NORTH DR.
MELBOURNE,  FL  32934
Correspondent Contact JAMES LUKER
Regulation Number870.2300
Classification Product Code
MWI  
Date Received12/26/2006
Decision Date 02/06/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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