Clearance Summary
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO received FDA 510(k) clearance under submission number K924383, sponsored by Synectics-Dantec. 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 1993-06-18.
- Submission: K924383
- Applicant / Sponsor: Synectics-Dantec
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 1993-06-18
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.