Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter For Controller 5525

Endoscopic Video Imaging System/component, Gastroenterology-urology

Richard Wolf Medical Instruments Corporation

The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Logic Hd Camera Controller, Logic Hd Lite Camera Controller, Logic 4k Camera Contoller, Adapter For Controller 5525.

Pre-market Notification Details

Device IDK200617
510k NumberK200617
Device Name:Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter For Controller 5525
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills,  IL  60061
ContactMichael Loiterman
CorrespondentMichael Loiterman
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills,  IL  60061
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-06-23

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