510(k) K080797 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HUMIDAIRE 2I
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Jul 9, 2008 |
| Received | Mar 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080797
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.