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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 K123254
Device Name ULTRASOUND SCANNER FLEX FOCUS
Applicant
B-K Medical Aps
Mileparken 34
Herlev,  DK DK-2730
Applicant Contact RANDI HAUERBERG
Correspondent
B-K Medical Aps
Mileparken 34
Herlev,  DK DK-2730
Correspondent Contact RANDI HAUERBERG
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/18/2012
Decision Date 02/13/2013
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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