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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name display, diagnostic radiology
510(k) Number K191137
Device Name 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
Applicant
JVC Kenwood Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama,  JP 221-0022
Applicant Contact Hideki Tengeiji
Correspondent
JVC Kenwood Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama,  JP 221-0022
Correspondent Contact Hideki Tengeiji
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/29/2019
Decision Date 07/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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