Clearance Summary
LEVELERT II FLUID LEVEL SENSOR received FDA 510(k) clearance under submission number K060123, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2006-02-14.
- Submission: K060123
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2420
- Decision date: 2006-02-14
Classification & Regulation
This clearance is catalogued under FDA product code FLN and 21 CFR 880.2420, within the General Hospital review panel as a Class II device.