510(k) K160764 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AirLife Autofill Humidification Chamber
| Applicant | Carefusion 2200, Inc., Vernon Hills IL, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Mar 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2018 | Vyaire Medical Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290.
The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) o Terminated |
BTT | None listed |
| Jan 24, 2018 | Vyaire Medical Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290.
The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) ope Terminated |
BTT | None listed |
| Jan 24, 2018 | Vyaire Medical Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290.
The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a sys Terminated |
BTT | None listed |
| Jan 24, 2018 | Vyaire Medical Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290.
The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.