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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 K063547
Device Name CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM
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  
Date Received11/24/2006
Decision Date 12/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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