Clearance Summary
BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002 received FDA 510(k) clearance under submission number K885092, sponsored by Medical Imaging Systems, 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 1989-03-10.
- Submission: K885092
- Applicant / Sponsor: Medical Imaging Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5220
- Decision date: 1989-03-10
Classification & Regulation
This clearance is catalogued under FDA product code KPL and 21 CFR 876.5220, within the Gastroenterology, Urology review panel as a Class II device.