510(k) K063758 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R
| Applicant | Teleflex Medical, Bannockburn IL, US |
| Decision | Substantially Equivalent, Apr 23, 2007 |
| Received | Dec 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2012 | Teleflex Medical Hudson RCI Concha Therm Neptune Humidifier, Rx Only,
Product Usage: Usage:
Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient. Terminated |
BTT | None listed |
| Mar 9, 2010 | Telefelx Medical Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30. Terminated |
BTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.