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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
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