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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 K933056
Device Name DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED
Applicant
B&K Medical
Sandtoften 9
Gentofte,  DK DK-2820
Applicant Contact VILLY BRAENDER
Correspondent
B&K Medical
Sandtoften 9
Gentofte,  DK DK-2820
Correspondent Contact VILLY BRAENDER
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/17/1993
Decision Date 06/24/1994
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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