510(k) K201620 · BZD Ventilator, Non-Continuous (Respirator)
Luna® G3 BPAP 25A
| Applicant | 3B Medical, Inc., Winter FL, US |
| Decision | Substantially Equivalent, Jan 29, 2021 |
| Received | Jun 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201620
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.