5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500

Display, Diagnostic Radiology

JVC Kenwood Corporation

The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 5mp Color Lcd Monitor Cl-s500, 5mp Monochrome Lcd Monitor Ms-s500.

Pre-market Notification Details

Device IDK191137
510k NumberK191137
Device Name:5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
ClassificationDisplay, Diagnostic Radiology
Applicant JVC Kenwood Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama,  JP 221-0022
ContactHideki Tengeiji
CorrespondentHideki Tengeiji
JVC Kenwood 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 Received2019-04-29
Decision Date2019-07-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00046838081033 K191137 000
00046838081026 K191137 000
00046838079979 K191137 000
00046838079962 K191137 000

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