K231561
- 510(k) number
- K231561
- Device name
- Pulmonary Function Tester, Model: A9
- Applicant
- Guangzhou Homesun Medical Technology Co., Ltd. CN
- Product code
- BTY — Calculator, Predicted Values, Pulmonary Function
- Decision date
- 2024-02-21
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231561.pdf
Official FDA record: K231561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.