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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 K024236
Device Name ULTRASOUND SCANNER, TYPE 2400
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 Received12/23/2002
Decision Date 01/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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