Clearance Summary
NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP received FDA 510(k) clearance under submission number K871848, sponsored by Panamedix, Inc.. 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 1988-02-03.
- Submission: K871848
- Applicant / Sponsor: Panamedix, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1988-02-03
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.