Clearance Summary
ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM received FDA 510(k) clearance under submission number K963064, sponsored by Laborie Medical Tech 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 1997-06-05.
- Submission: K963064
- Applicant / Sponsor: Laborie Medical Tech Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1997-06-05
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.