510(k) K131912 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
| Applicant | Teleflex, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Mar 6, 2014 |
| Received | Jun 26, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit Terminated |
BTT | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit Terminated |
BTT | None listed |
| Apr 30, 2015 | Teleflex Medical Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.