Peak flow meter— 510(k) K203196

Name: FDA 510(k) clearance K203196
Creator: U.S. Food and Drug Administration
Published: 2021-05-26

Substantially Equivalent

Shanghai Sonmol Medical Equipment Co., Ltd.

FDA 510(k) clearance K203196 for Peak flow meter, Substantially Equivalent on 2021-05-26. Applicant: Shanghai Sonmol Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Sonmol Medical Equipment Co., Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2020-10-28
Decision date: 2021-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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