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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 K142536
Device Name 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
Applicant
JVC KENWOOD CORPORATION
3-12, MORIYACHO, KANAGAWA-KU
YOKOHAMA-SHI,  JP 221-0022
Applicant Contact TSUKASA TASHIRO
Correspondent
JVC KENWOOD CORPORATION
3-12, MORIYACHO, 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
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