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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 K210345
Device Name 2MP Monochrome LCD Monitor MS-S200
Applicant
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama,  JP 221-0022
Applicant Contact Hideki Tengeiji
Correspondent
Jvckenwood Corporation
3-12, Moriya-Cho, Kanagawa-Ku
Yokohama,  JP 221-0022
Correspondent Contact Hideki Tengeiji
Regulation Number892.2050
Classification Product Code
PGY  
Date Received02/05/2021
Decision Date 04/23/2021
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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