510(k) K243394 ยท CBK Ventilator, Continuous, Facility Use
AF531 Oro-Nasal SE Face Mask
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Dec 30, 2024 |
| Received | Oct 31, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243394
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.