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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
Applicant
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact SUSAN E MANDY
Correspondent
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Correspondent Contact SUSAN E MANDY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/29/2003
Decision Date 02/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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