510(k) K253479 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
| Applicant | Fisher & Paykel Healthcare, Ltd., Auckland, NZ |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Oct 14, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253479
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.