510(k) K203126 ยท BZD Ventilator, Non-Continuous (Respirator)
S10 Kirra
| Applicant | Resmed Pty , Ltd., Bella Vista, AU |
| Decision | Substantially Equivalent, Dec 18, 2020 |
| Received | Oct 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203126
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.