Smart Peak Flow Meter— 510(k) K191239

Name: FDA 510(k) clearance K191239
Creator: U.S. Food and Drug Administration
Published: 2019-12-06

Substantially Equivalent

Guangzhou Homesun Medical Technology Co., Ltd.

FDA 510(k) clearance K191239 for Smart Peak Flow Meter, Substantially Equivalent on 2019-12-06. Applicant: Guangzhou Homesun Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Homesun Medical Technology Co., Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2019-05-08
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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