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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 K011417
Device Name ULTRASOUND SCANNER, TYPE 2102
Applicant
B-K Medical A/S
Sandtoften 9
Gentofte,  DK DK-2820
Applicant Contact VILLY BRAENDER
Correspondent
B-K Medical A/S
Sandtoften 9
Gentofte,  DK DK-2820
Correspondent Contact VILLY BRAENDER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/09/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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