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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 K081921
Device Name GE VIVID E9 ULTRASOUND
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 Number892.1550
Classification Product Code
IYN  
Date Received07/07/2008
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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