510(k) K252965 ยท CAW Generator, Oxygen, Portable
Oxygen Concentrator (OX-5A, OX-5C)
| Applicant | Oxytek Medical Technology Co., Ltd., Chencun Town, Shunde District, Foshan, CN |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Sep 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252965
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.