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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 K101571
Device Name XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS
Original Applicant
WITT BIOMEDICAL CORP
305 north dr.
melbourne,  FL  32934
Original Contact james luker
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQK  
Date Received06/04/2010
Decision Date 10/26/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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