510(k) K172804

Besmed Peak Flow Meter by Besmed Health Business Corp — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2018
Date Received
September 18, 2017
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