510(k) K162242 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Comfort Flo Humidification System
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Jan 19, 2017 |
| Received | Aug 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162242
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit Terminated |
BTT | None listed |
| Feb 7, 2020 | TELEFLEX MEDICAL INC HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.