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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
Original Applicant
WITT BIOMEDICAL CORP
305 north dr.
melbourne,  FL  32934
Original Contact elfriede pagan
Regulation Number870.2300
Classification Product Code
MWI  
Date Received09/26/2003
Decision Date 02/24/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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