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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 K142540
Device Name 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
Applicant
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama-Shi,  JP 221-0022
Applicant Contact Tsukasa Tashiro
Correspondent
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama-Shi,  JP 221-0022
Correspondent Contact Tsukasa Tashiro
Regulation Number892.2050
Classification Product Code
PGY  
Date Received09/09/2014
Decision Date 10/03/2014
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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