Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Peak flow meter

K-Number: K203196 · 2021-05-26

Decision Date2021-05-26
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Peak flow meter is a medical device manufactured by Shanghai Sonmol Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-26 under approval number K203196. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Peak flow meter?

Peak flow meter is a medical device that received FDA 510(k) clearance on 2021-05-26. It is manufactured by Shanghai Sonmol Medical Equipment Co., Ltd.. The 510(k) number is K203196.

When was Peak flow meter approved by the FDA?

Peak flow meter received FDA 510(k) clearance on 2021-05-26, under approval number K203196.

What company makes Peak flow meter?

Peak flow meter is manufactured by Shanghai Sonmol Medical Equipment Co., Ltd..

What is the FDA product code for Peak flow meter?

The FDA product code for Peak flow meter is BZH.

Related Devices (Code: BZH)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.