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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 north dr.
melbourne,  FL  32934
Contact james luker
Regulation Number870.2300
Classification Product Code
MWI  
Date Received11/24/2006
Decision Date 12/21/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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