510(k) K151461 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Hybernite RT
| Applicant | Plastiflex Group NV, Paal-Beringen, BE |
| Decision | Substantially Equivalent, Mar 24, 2016 |
| Received | Jun 1, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151461
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.