K241843
- 510(k) number
- K241843
- Device name
- TD-7301 Spirometer (TD-7301)
- Applicant
- Gostar Co., Ltd. TW
- Product code
- BZG — Spirometer, Diagnostic
- Decision date
- 2024-11-20
- Date received
- 2024-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K241843.pdf
Official FDA record: K241843
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.