Clearance Summary
OXFORD OPTRONIX MPM 3S received FDA 510(k) clearance under submission number K914397, sponsored by Dia-Stron, Ltd.. 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 1992-11-16.
- Submission: K914397
- Applicant / Sponsor: Dia-Stron, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1992-11-16
Classification & Regulation
This clearance is catalogued under FDA product code FTI and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.