510(k) K162553 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AirSpiral Heated Breathing Tube
| Applicant | Fisher & Paykel Healthcare, Auckland, NZ |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Sep 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162553
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.