510(k) K244035 ยท CAF Nebulizer (Direct Patient Interface)
Portable mesh nebulizer (JM821)
| Applicant | Shenzhen Jermei Medical Device Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Dec 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K244035
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.