Clearance Summary
RECTUM-COLON MOTILITY MONITOR received FDA 510(k) clearance under submission number K884920, sponsored by Multi-Spectrum Consulting, 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 1989-12-08.
- Submission: K884920
- Applicant / Sponsor: Multi-Spectrum Consulting, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1989-12-08
Classification & Regulation
This clearance is catalogued under FDA product code FAP and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.