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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
Applicant
Witt Biomedical Corp
305 N. Dr.
Melbourne,  FL  32934
Applicant Contact JAMES LUKER
Correspondent
Witt Biomedical Corp
305 N. Dr.
Melbourne,  FL  32934
Correspondent 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 (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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