K244035
- 510(k) number
- K244035
- Device name
- Portable mesh nebulizer (JM821)
- Applicant
- Shenzhen Jermei Medical Device Technology Co., Ltd. CN
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2025-09-19
- Date received
- 2024-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K244035.pdf
Official FDA record: K244035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.