510(k) K034026 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jan 12, 2005 |
| Received | Dec 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034026
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.