510(k) K253553 ยท BZD Ventilator, Non-Continuous (Respirator)
Orion
| Applicant | Resmed Corp, San Diego CA, US |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | Nov 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253553
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.