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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K915342
Device Name UD 2000 VIDEO OPTION
Applicant
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Applicant Contact GERALD MCMORROW
Correspondent
Diagnostic Ultrasound Corp.
P.O. Box 0789
Kirkland,  WA  98083
Correspondent Contact GERALD MCMORROW
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/26/1991
Decision Date 06/10/1992
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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