K242354
- 510(k) number
- K242354
- Device name
- AllNEB
- Applicant
- Enchant Tek Co. , Ltd. TW
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2025-04-29
- Date received
- 2024-08-08
- 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: K242354.pdf
Official FDA record: K242354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.