TD-7301 Peak Flow meter— 510(k) K222810

Substantially Equivalent

Gostar Co., Ltd.

FDA 510(k) clearance K222810 for TD-7301 Peak Flow meter, Substantially Equivalent on 2023-12-19. Applicant: Gostar Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gostar Co., Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2022-09-16
Decision date: 2023-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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K230423 — Electronic Peak Flow Meter2024-02-23

More clearances from Gostar Co., Ltd.

K241843 — TD-7301 Spirometer (TD-7301)2024-11-20
K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets2023-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.