510(k) K132127 ยท BZD Ventilator, Non-Continuous (Respirator)
TRANSCEND AUTO
| Applicant | Somnetics International, Inc., New Brighton MN, US |
| Decision | Substantially Equivalent, Oct 17, 2013 |
| Received | Jul 10, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132127
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.