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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 K180737
Device Name Ultrasound Scanner System bk2300
Applicant
Bk Medical Aps
Mileparken 34
Herlev,  DK 2730
Applicant Contact Susana Mogensen
Correspondent
Bk Medical Aps
Mileparken 34
Herlev,  DK 2730
Correspondent Contact Susana Mogensen
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/22/2018
Decision Date 08/01/2018
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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