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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 K041907
Device Name TRIO MONITOR
Applicant
DATASCOPE CORP.
800 MACARTHUR BLVD.
MAHWAH,  NJ  07430 -0619
Applicant Contact SUSAN E MANDY
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact BAHRAM BARZIDEH
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/15/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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