510(k) K080149 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HEATER BASE, MODEL PMH7000
| Applicant | Pacific Medico Co., Ltd., Tokyo, JP |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Jan 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080149
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.