Clearance Summary
NAVIAID BGE DEVICE, MODEL 21-001 received FDA 510(k) clearance under submission number K060923, sponsored by Smart Medical Systems , Ltd.. 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 2006-08-15.
- Submission: K060923
- Applicant / Sponsor: Smart Medical Systems , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-08-15
Classification & Regulation
This clearance is catalogued under FDA product code FDA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.