Cleared Traditional

TD-7301 Peak Flow meter

K222810 · Gostar Co., Ltd. · Anesthesiology

Dec 2023

Decision

459d

Days

Class 2

Risk

About This 510(k) Submission

K222810 is an FDA 510(k) clearance for the TD-7301 Peak Flow meter, a Meter, Peak Flow, Spirometry (Class II — Special Controls, product code BZH), submitted by Gostar Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on December 19, 2023, 459 days after receiving the submission on September 16, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1860.

Submission Details

510(k) Number	K222810 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2022
Decision Date	December 19, 2023
Days to Decision	459 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF