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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 K060542
Device Name GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
Applicant
General Electric Co.
4855 Westelectric Ave.
P.O. Box 414
Milwaukee,  WI  53219
Applicant Contact ALLEN SCHUH
Correspondent
General Electric Co.
P.O. Box 7550
Madison,  WI  53707
Correspondent Contact Monica Morrison
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/01/2006
Decision Date 03/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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