510(k) K234134 ยท BZD Ventilator, Non-Continuous (Respirator)
AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
| Applicant | Resmed Pty Ltd (Registration Number: 3004604967), Bella Vista, AU |
| Decision | Substantially Equivalent, Sep 24, 2024 |
| Received | Dec 29, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K234134
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.