Cleared Traditional

Peak flow meter

K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · Anesthesiology
May 2021
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K203196 is an FDA 510(k) clearance for the Peak flow meter, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Shanghai Sonmol Medical Equipment Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on May 26, 2021, 210 days after receiving the submission on October 28, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K203196 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2020
Decision Date May 26, 2021
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZH — Meter, Peak Flow, Spirometry
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1860