Clearance Summary
ENTERAL PUMP SET, MODEL 20-1010 received FDA 510(k) clearance under submission number K081725, sponsored by Viasys Medsystems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2008-11-07.
- Submission: K081725
- Applicant / Sponsor: Viasys Medsystems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2008-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.