Cleared Traditional

Peak Flow Meter

K241338 · Chongqing Moffy Innovation Technology Co., Ltd. · Anesthesiology
Dec 2024
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K241338 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 Chongqing Moffy Innovation Technology Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on December 31, 2024, 232 days after receiving the submission on May 13, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number K241338 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date December 31, 2024
Days to Decision 232 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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