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510(k) K181666

Smart One by Mir Medical International Research — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2018
Date Received
June 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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