Clearance Summary
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K062340, sponsored by Cardio-Optics, 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 2006-11-30.
- Submission: K062340
- Applicant / Sponsor: Cardio-Optics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2006-11-30
Classification & Regulation
This clearance is catalogued under FDA product code LYK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.