Clearance Summary
ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS received FDA 510(k) clearance under submission number K011868, sponsored by Debio Tech SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2001-09-04.
- Submission: K011868
- Applicant / Sponsor: Debio Tech SA
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2001-09-04
Classification & Regulation
This clearance is catalogued under FDA product code LZH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.