K250583
- 510(k) number
- K250583
- Device name
- AdheResp Smart Breath-actuated Mesh Nebulizer
- Applicant
- Hcmed Innovations Co., Ltd. TW
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2025-06-20
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250583.pdf
Official FDA record: K250583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.