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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K200944
Device Name UNIEXPERT 2 PLUS
Applicant
Adani
7 Selitsky St.
Minsk,  BY 220075
Applicant Contact Vladimir Linev
Correspondent
Adani
7 Selitsky St.
Minsk,  BY 220075
Correspondent Contact Vladimir Linev
Regulation Number892.1680
Classification Product Code
KPR  
Date Received04/08/2020
Decision Date 05/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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