K230602
- 510(k) number
- K230602
- Device name
- Hudson RCI® TurboMist Nebulizer System
- Applicant
- Medline Industries, LP IL · US
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2023-10-31
- Date received
- 2023-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230602.pdf
Official FDA record: K230602
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.