K222810
- 510(k) number
- K222810
- Device name
- TD-7301 Peak Flow meter
- Applicant
- Gostar Co., Ltd. TW
- Product code
- BZH — Meter, Peak Flow, Spirometry
- Decision date
- 2023-12-19
- Date received
- 2022-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K222810.pdf
Official FDA record: K222810
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.