Clearance Summary
URDYN 5000 (UROFLOWMETER) received FDA 510(k) clearance under submission number K860368, 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 1986-04-23.
- Submission: K860368
- Applicant / Sponsor: Dantec Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1986-04-23
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.