2MP Monochrome LCD Monitor MS-S200

Display, Diagnostic Radiology

Jvckenwood Corporation

The following data is part of a premarket notification filed by Jvckenwood Corporation with the FDA for 2mp Monochrome Lcd Monitor Ms-s200.

Pre-market Notification Details

Device IDK210345
510k NumberK210345
Device Name:2MP Monochrome LCD Monitor MS-S200
ClassificationDisplay, Diagnostic Radiology
Applicant Jvckenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama,  JP 221-0022
ContactHideki Tengeiji
CorrespondentHideki Tengeiji
Jvckenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama,  JP 221-0022
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-05
Decision Date2021-04-23

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