510(k) K993355 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, May 24, 2000 |
| Received | Oct 6, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993355
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Teleflex Medical HUDSON RCI, Humidifier Adaptor, Rx only, Teleflex Medical, Research Triangle Park, NC 27709.
Use to add water vapor to a dry medical gas for administration to a patient. Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.