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510(k) K041907

TRIO MONITOR by Datascope Corp. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2004
Date Received
July 15, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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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