510(k) K212263 ยท BZD Ventilator, Non-Continuous (Respirator)
Luna G3 BPAP System
| Applicant | 3B Medical, Inc., Winter FL, US |
| Decision | Substantially Equivalent, Mar 25, 2022 |
| Received | Jul 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212263
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.