510(k) K213825 ยท CAW Generator, Oxygen, Portable
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., Danyang, CN |
| Decision | Substantially Equivalent, Apr 28, 2023 |
| Received | Dec 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213825
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.