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510(k) K160116

SpiroScout by Ganshorn Medizin Electronic GmbH — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2016
Date Received
January 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Diagnostic
Device Class
Class II
Regulation Number
868.1840
Review Panel
AN
Submission Type

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