510(k) K780456 ยท CAF Nebulizer (Direct Patient Interface)
NEBULIZER HEATER
| Applicant | Travenol Laboratories, S.A., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 12, 1978 |
| Received | Mar 21, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K780456
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2011 | Carefusion 211 Inc AirLife Nebulizer Heater, Catalog Code 2M8021
The AirLife Nebulizer Heater is part of the heated nebulizer system intended to provide warm bland aerosol therapy to respiratory patients. The system is Terminated |
CAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.