510(k) K180388 ยท BZD Ventilator, Non-Continuous (Respirator)
Transcend 365 miniCPAP System
| Applicant | Somnetics International, Inc., New Brighton MN, US |
| Decision | Substantially Equivalent, Nov 30, 2018 |
| Received | Feb 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180388
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.