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510(k) K071805

NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX by Datascope Corp. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2007
Date Received
July 2, 2007
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

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  • K062754 — GAS MODULE SE, MODEL 0998-00-0481-02 (November 2, 2006)

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