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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
Predetermined Change
Control Plan Authorized		 No
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