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510(k) K062754

GAS MODULE SE, MODEL 0998-00-0481-02 by Datascope Corp. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2006
Date Received
September 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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