510(k) K160540 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM
| Applicant | Flexicare Medical Limited., Mountain Ash, GB |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Feb 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160540
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.