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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 K032338
Device Name TRIO MONITOR MODEL 0998-00-0600
Original Applicant
DATASCOPE CORP.
800 macarthur blvd.
mahwah,  NJ  07430 0619
Original Contact susan e mandy
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/29/2003
Decision Date 02/11/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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