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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 K173569
Device Name Ultrasound System 1300
Applicant
Bk Medical Aps
Mileparken 34
Herlev,  DK 2730
Applicant Contact Karen Provencher
Correspondent
Bk Medical Aps
Mileparken 34
Herlev,  DK 2730
Correspondent Contact Karen Provencher
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/20/2017
Decision Date 02/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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