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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 K150145
Device Name MD322C8 31.5 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
New Taipei City,  TW
Correspondent Contact TONY HSU
Regulation Number892.2050
Classification Product Code
PGY  
Date Received01/22/2015
Decision Date 02/06/2015
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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