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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 K200161
Device Name 3MP Monochrome Digital Mammography LCD Monitor MS-S300
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 Received01/22/2020
Decision Date 02/21/2020
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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