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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 K033030
Device Name CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM
Applicant
WITT BIOMEDICAL CORP
305 north dr.
melbourne,  FL  32934
Contact elfriede pagan
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/26/2003
Decision Date 02/24/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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