510(k) K250583 ยท CAF Nebulizer (Direct Patient Interface)
AdheResp Smart Breath-actuated Mesh Nebulizer
| Applicant | Hcmed Innovations Co., Ltd., Taipei City, TW |
| Decision | Substantially Equivalent, Jun 20, 2025 |
| Received | Feb 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250583
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.