510(k) K242547 ยท BZD Ventilator, Non-Continuous (Respirator)
AirFit F20 Mask System; AirFit F20 NM Mask System
| Applicant | Resmed Pty , Ltd., Bella Vista, AU |
| Decision | Substantially Equivalent, May 19, 2025 |
| Received | Aug 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242547
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.