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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 K211248
Device Name ArtUs
Applicant
Telemed
Highway Business Centre Savanoriu pr. 178A
Vilnius,  LT LT-03154
Applicant Contact Yury Sokolov
Correspondent
Telemed
Highway Business Centre Savanoriu pr. 178A
Vilnius,  LT LT-03154
Correspondent Contact Yury Sokolov
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/26/2021
Decision Date 02/11/2022
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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