Clearance Summary
MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY received FDA 510(k) clearance under submission number K000669, sponsored by Medivision Endoscopy. 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 2000-05-26.
- Submission: K000669
- Applicant / Sponsor: Medivision Endoscopy
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-05-26
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.