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510(k) K161676

Q13 SPIROLYSER® by Fim Medical — Product Code BZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2016
Date Received
June 17, 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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  • K010761 — SPL-50 SPIROLYSER (March 5, 2002)

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