510(k) K183512 ยท BZD Ventilator, Non-Continuous (Respirator)
Moore Park Mask
| Applicant | Resmed, Ltd., Bella Vista Nsw 2153, AU |
| Decision | Substantially Equivalent, May 7, 2019 |
| Received | Dec 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183512
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2023 | ResMed Ltd. AirFit F30i Full Face Mask and User Guide Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.