510(k) K203196

Peak flow meter by Shanghai Sonmol Medical Equipment Co., Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2021
Date Received
October 28, 2020
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