510(k) K250671 ยท CAW Generator, Oxygen, Portable
FreeStyle Comfort (AS200 / FreeStyle Comfort)
| Applicant | Caire, Inc., Ball Ground GA, US |
| Decision | Substantially Equivalent, Jul 11, 2025 |
| Received | Mar 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250671
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.