510(k) K822959
K822959 is an FDA 510(k) premarket notification submitted by Eder Instrument Co, Inc. for the device "ENDOSCOPIC VIDEOSYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 1982. The device falls under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Eder Instrument Co, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1982
- Date Received
- October 5, 1982
- Clearance Type
- Traditional
- 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.