Cleared Traditional

Electronic Peak Flow Meter

K230423 · Taian Dalu Medical Instrument Co., Ltd. · Anesthesiology
Feb 2024
Decision
371d
Days
Class 2
Risk

About This 510(k) Submission

K230423 is an FDA 510(k) clearance for the Electronic Peak Flow Meter, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Taian Dalu Medical Instrument Co., Ltd. (Taian City, CN). The FDA issued a Cleared decision on February 23, 2024, 371 days after receiving the submission on February 17, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K230423 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2023
Decision Date February 23, 2024
Days to Decision 371 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