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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 K043524
Device Name ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
Applicant
B-K MEDICAL A/S
MILEPARKEN 34
HERLEV,  DK DK-2730
Applicant Contact VILLY BRAENDER
Correspondent
B-K MEDICAL A/S
MILEPARKEN 34
HERLEV,  DK DK-2730
Correspondent Contact VILLY BRAENDER
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/20/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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