510(k) K243244 ยท BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Heated Breathing Tube
| Applicant | Guangdong Eda Technology Co., Ltd., Guangdong Province, CN |
| Decision | Substantially Equivalent, Jul 25, 2025 |
| Received | Oct 11, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243244
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.