510(k) K231561 ยท BTY Calculator, Predicted Values, Pulmonary Function
Pulmonary Function Tester, Model: A9
| Applicant | Guangzhou Homesun Medical Technology Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Feb 21, 2024 |
| Received | May 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231561
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.