Clearance Summary
SONY DXC-LS1 COLOR VIDEO CAMERA received FDA 510(k) clearance under submission number K980279, sponsored by Sony Medical Electronics Co.. 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 1998-04-24.
- Submission: K980279
- Applicant / Sponsor: Sony Medical Electronics Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1998-04-24
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.