Clearance Summary
MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6 received FDA 510(k) clearance under submission number K040244, sponsored by The Microoptical Corporation. 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 2004-03-24.
- Submission: K040244
- Applicant / Sponsor: The Microoptical Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2004-03-24
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.