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510(k) K051897

TRIO MONITOR by Datascope Corp. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2005
Date Received
July 13, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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