510(k) K100104 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
HYBERNITE RAINOUT CONTROL SYSTEM
| Applicant | Plastiflex Group NV, Claremont NH, US |
| Decision | Substantially Equivalent, Apr 14, 2010 |
| Received | Jan 13, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100104
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.