ENDOSCOPY VIDEO CAMERA SYSTEM— 510(k) K081585
Substantially EquivalentVision Systems Group, A Division of Viking Systems
FDA 510(k) clearance K081585 for ENDOSCOPY VIDEO CAMERA SYSTEM, Substantially Equivalent on 2008-06-20. Applicant: Vision Systems Group, A Division of Viking Systems. Device class: 2.
Clearance details
- Applicant
- Vision Systems Group, A Division of Viking Systems
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Grafton, MA, US
Recent devices under product code FET
view allMore clearances from Vision Systems Group, A Division of Viking Systems
view allAdverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.