510(k) K261262 ยท BZD Ventilator, Non-Continuous (Respirator)
Altis Full Face Mask
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Apr 16, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261262
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.