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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 K173434
Device Name 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
Applicant
JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama,  JP 221-0022
Applicant Contact Masafumi Yugami
Correspondent
JVC KENWOOD Corporation
3-12, Moriya-cho, Kanagawa-ku
Yokohama,  JP 221-0022
Correspondent Contact Masafumi Yugami
Regulation Number892.2050
Classification Product Code
PGY  
Date Received11/02/2017
Decision Date 12/14/2017
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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