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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.
Mahwh,  NJ  07430
Applicant Contact SUSAN E MANDY
Correspondent
Datascope Corp.
800 Macarthur Blvd.
Mahwh,  NJ  07430
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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