510(k) K103767 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
DUAL HEATED INFANT VREATHING CIROUITS
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Apr 16, 2012 |
| Received | Dec 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103767
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.