FDA.report

510(k) K191137

Device
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
Applicant
JVC Kenwood Corporation
510(k) number
K191137
Product code
PGY  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-02
Date received
2019-04-29
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Hideki Tengeiji
Address
3-12, Moriya-Cho, Kanagawa-Ku Yokohama JP 221-0022 221-0022

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00046838081033JVCJVC KENWOOD CORPORATION2020-01-20
00046838081026JVCJVC KENWOOD CORPORATION2020-01-20
00046838079979JVCJVC KENWOOD CORPORATION2019-07-30
00046838079962JVCJVC KENWOOD CORPORATION2019-07-30

Legacy Summary

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FDA Review

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