Clearance Summary
URODYN 1000 received FDA 510(k) clearance under submission number K853119, sponsored by Dantec Electronics, 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 1985-10-04.
- Submission: K853119
- Applicant / Sponsor: Dantec Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1985-10-04
Classification & Regulation
This clearance is catalogued under FDA product code FFO and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.