510(k) K241778
K241778 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "Hudson RCI Comfort Flo® CubCannula". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2024
- Date Received
- June 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type