2MP Color LCD Monitor CCL214 (CL21214)

Display, Diagnostic Radiology

JVC KENWOOD Corporation

The following data is part of a premarket notification filed by Jvc Kenwood Corporation with the FDA for 2mp Color Lcd Monitor Ccl214 (cl21214).

Pre-market Notification Details

Device IDK161895
510k NumberK161895
Device Name:2MP Color LCD Monitor CCL214 (CL21214)
ClassificationDisplay, Diagnostic Radiology
Applicant JVC KENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama,  JP 221-0022
ContactTsukasa Tashiro
CorrespondentTsukasa Tashiro
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 Received2016-07-11
Decision Date2016-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04996005103562 K161895 000
00046838076626 K161895 000

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