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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 K896029
Device Name DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
Applicant
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Applicant Contact GEORG BOHSACK
Correspondent
G.W.B. Intl., Ltd.
P.O. Box 801
Sudbury,  MA  01776
Correspondent Contact GEORG BOHSACK
Regulation Number892.1560
Classification Product Code
IYO  
Date Received10/17/1989
Decision Date 01/12/1990
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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