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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 Echo, Ultrasonic
510(k) Number K132346
Device Name ULTRASOUND SCANNER PRO FOCUS 2202
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 Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received07/29/2013
Decision Date 01/10/2014
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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