510(k) K092256 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012
| Applicant | Smiths Medical Asd, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Oct 20, 2010 |
| Received | Jul 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092256
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.