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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 K061682
Device Name GE VOLUSON E8 ULTRASOUND SYSTEM
Applicant
GENERAL ELECTRIC CO.
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact ALLEN SCHUH
Correspondent
GENERAL ELECTRIC CO.
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact ALLEN SCHUH
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received06/15/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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