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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 K020789
Device Name GE VIVID 3 EXPERT; GE VIVID 3 PRO
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact ALLEN SCHUH
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
IYO  
Date Received03/11/2002
Decision Date 04/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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