K250312
- 510(k) number
- K250312
- Device name
- Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
- Applicant
- Medline Industries, LP IL · US
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2025-07-02
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250312.pdf
Official FDA record: K250312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.