510(k) K150304
K150304 is an FDA 510(k) premarket notification submitted by Oxyless, Ltd. for the device "Oxyless Blood Tubing Set". The FDA issued a decision of Substantially Equivalent on February 24, 2016. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 2016
- Date Received
- February 6, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type