510(k) K113542 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
| Applicant | Salter Labs, Arvin Facility, Arvin CA, US |
| Decision | Substantially Equivalent, Feb 10, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113542
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.