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510(k) K934502

FLOW SPIROMETER by Healthdyne, Inc. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1994
Date Received
September 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

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