510(k) K250625 ยท CAW Generator, Oxygen, Portable
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
| Applicant | Nanjing Yinuoji Medical Technology Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | Mar 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250625
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.