510(k) K201200
K201200 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Visera Elite II Video System Center". The FDA issued a decision of Substantially Equivalent on July 22, 2020. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2020
- Date Received
- May 4, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.