510(k) K131388 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
TRANSCEND HEATED HUMIDIFIER
| Applicant | Somnetics International, Inc., New Brighton MN, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | May 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131388
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.