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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K161968
Device Name MicrUs
Applicant
TELEMED
Dariaus ir Gireno str.42
Vilnius,  LT LT-02189
Applicant Contact Yury Sokolov
Correspondent
Medical Imaging Innovations
Dariaus ir Gireno str. 42
Vilnius,  LT
Correspondent Contact Yury Sokolov
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/18/2016
Decision Date 11/03/2016
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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