510(k) K050314 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
AQUINOX
| Applicant | Smiths Medical Asd, Inc., Wampsville NY, US |
| Decision | Substantially Equivalent, Feb 18, 2005 |
| Received | Feb 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050314
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.