510(k) K121975 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Jan 3, 2013 |
| Received | Jul 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121975
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.