510(k) K170378 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
AirLife Adult Heated Wire BiPAP/NIV Circuit
| Applicant | Vyaire Medical, Vernon Hills IL, US |
| Decision | Substantially Equivalent, Sep 14, 2017 |
| Received | Feb 7, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170378
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.