ENDOSCOPY VIDEO CAMERA SYSTEM

Endoscopic Video Imaging System/component, Gastroenterology-urology

VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS

The following data is part of a premarket notification filed by Vision Systems Group, A Division Of Viking Systems with the FDA for Endoscopy Video Camera System.

Pre-market Notification Details

Device IDK081585
510k NumberK081585
Device Name:ENDOSCOPY VIDEO CAMERA SYSTEM
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 10 GREENLAWN AVE South Grafton,  MA  01560
ContactChristine E Nichols
CorrespondentChristine E Nichols
VISION SYSTEMS GROUP, A DIVISION OF VIKING SYSTEMS 10 GREENLAWN AVE South Grafton,  MA  01560
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-05
Decision Date2008-06-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.