510(k) K262268 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Optiflow Oxygen Kit (AA484J)
| Applicant | Fisher and Paykel Healthcare Limited, Auckland, NZ |
| Decision | Substantially Equivalent, Aug 27, 2026 |
| Received | Jul 6, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K262268
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.