Cleared Traditional

Besmed Peak Flow Meter

K172804 · Besmed Health Business Corp · Anesthesiology
Jan 2018
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K172804 is an FDA 510(k) clearance for the Besmed Peak Flow Meter, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Besmed Health Business Corp (Wu-Ku District, TW). The FDA issued a Cleared decision on January 11, 2018, 115 days after receiving the submission on September 18, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K172804 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2017
Decision Date January 11, 2018
Days to Decision 115 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

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