D Camera Controller

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 D Camera Controller.

Pre-market Notification Details

Device IDK211332
510k NumberK211332
Device Name:D Camera Controller
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 Received2021-05-03
Decision Date2021-10-01

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