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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 K142951
Device Name MD210C3 21.3 Diagnostic Imaging LCD Monitor
Applicant
Nec Display Solutions , Ltd.
4-28 Mita 1-Chome, Minato-Ku,Tokyo, 108-0023
Tokyo,  JP 108-0023
Applicant Contact Satoru Kotani
Correspondent
Prodigy Technology Consultant Co., Ltd.
1f, # 181, Sec.2, Wunhua 1st Rd.
Linkou Township
Linkuo,  TW 24447
Correspondent Contact Tony Hsu
Regulation Number892.2050
Classification Product Code
PGY  
Date Received10/10/2014
Decision Date 12/10/2014
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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