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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 K160326
Device Name 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
Applicant
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama,  JP 221-0022
Applicant Contact Tsukasa Tashiro
Correspondent
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama,  JP 221-0022
Correspondent Contact Tsukasa Tashiro
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/05/2016
Decision Date 02/23/2016
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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