Clearance Summary
BELZER-MPS received FDA 510(k) clearance under submission number K972066, sponsored by Trans-Med Corp.. 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 1997-11-26.
- Submission: K972066
- Applicant / Sponsor: Trans-Med Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5880
- Decision date: 1997-11-26
Classification & Regulation
This clearance is catalogued under FDA product code KDN and 21 CFR 876.5880, within the Gastroenterology, Urology review panel as a Class II device.