K231058
- 510(k) number
- K231058
- Device name
- Hudson RCI® AddiPak® Unit Dose Vial
- Applicant
- Medline Industries, LP IL · US
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2024-01-04
- Date received
- 2023-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K231058.pdf
Official FDA record: K231058
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.