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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 K123564
FOIA Releasable 510(k) K123564
Device Name LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
GE HEALTHCARE
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE HEALTHCARE
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/20/2012
Decision Date 12/18/2012
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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