510(k) K131895 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
| Applicant | Fisher & Paykel Healthcare, Ltd., Manukau, NZ |
| Decision | Substantially Equivalent, Oct 24, 2013 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131895
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2025 | Fisher & Paykel Healthcare, Ltd. Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723 Open, Classified |
BTT | None listed |
| May 15, 2024 | Fisher & Paykel Healthcare, Ltd. Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US Open, Classified |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.