510(k) K233555 ยท BZD Ventilator, Non-Continuous (Respirator)
AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
| Applicant | Philips Respironics, Murrysville PA, US |
| Decision | Substantially Equivalent, Jul 31, 2024 |
| Received | Nov 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233555
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.