510(k) K254289 ยท CAW Generator, Oxygen, Portable
Portable Oxygen Concentrator (OX-1A-E, OX-1B)
| Applicant | Oxytek Medical Technology Co., Ltd., Chencun Town, Shunde District, Foshan, CN |
| Decision | Substantially Equivalent, Sep 23, 2026 |
| Received | Dec 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254289
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.