510(k) K201418 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Sunset Heated CPAP Tube
| Applicant | Sunset Healthcare Solutions, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Jan 29, 2021 |
| Received | May 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201418
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.