510(k) K241268 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
| Applicant | Exceleron Medical, St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 2, 2024 |
| Received | May 6, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241268
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.