510(k) K032338

TRIO MONITOR MODEL 0998-00-0600 by Datascope Corp. — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2004
Date Received
July 29, 2003
Clearance Type
Abbreviated
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