Clearance Summary
DIGI -FLOW received FDA 510(k) clearance under submission number K920671, sponsored by D and D Technology, 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 1993-01-28.
- Submission: K920671
- Applicant / Sponsor: D and D Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1993-01-28
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.