510(k) K161314 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
| Applicant | Flexicare Medical Limited., Mountain Ash, GB |
| Decision | Substantially Equivalent, Jul 6, 2016 |
| Received | May 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161314
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.