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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
Dariaus ir Gireno str.42
vilnius,  LT lt-02189
Applicant Contact yury sokolov
Medical Imaging Innovations
Dariaus ir Gireno str. 42
vilnius,  LT
Correspondent Contact yury sokolov
Regulation Number892.1560
Classification Product Code
Subsequent Product Code
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