TD-7301 Spirometer (TD-7301)— 510(k) K241843

Substantially Equivalent

Gostar Co., Ltd.

FDA 510(k) clearance K241843 for TD-7301 Spirometer (TD-7301), Substantially Equivalent on 2024-11-20. Applicant: Gostar Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gostar Co., Ltd.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2024-06-26
Decision date: 2024-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZG

K251777 — MESI mTABLET SPIRO2026-03-02
K231416 — Air Next (NVD-02)2024-01-18
K230501 — Spirobank Oxi2023-12-15
K230178 — EasyOne Sky Spirometer2023-10-19
K222525 — Alveoair Digital Spirometer2023-08-28

More clearances from Gostar Co., Ltd.

K222810 — TD-7301 Peak Flow meter2023-12-19
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.