510(k) K071958 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS
| Applicant | Smiths Medical Asd, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Nov 21, 2007 |
| Received | Jul 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071958
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.