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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 doppler, ultrasonic
510(k) Number K163121
Device Name SmartUs EXT-1M/3M
Applicant
TELEMED
DARIAUS IR GIRENO
STR.42
VILNIUS,  LT LT-02189
Applicant Contact YURY SOKOLOV
Correspondent
TELEMED
DARIAUS IR GIRENO
STR.42
VILNIUS,  LT LT-02189
Correspondent Contact YURY SOKOLOV
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/08/2016
Decision Date 08/10/2017
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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