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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 K110943
FOIA Releasable 510(k) K110943
Device Name LOGIQ E9
Applicant
GE HEALTHCARE
9900 INNOVATION DRIVE
RP-2138
WAUWATOSA,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE HEALTHCARE
9900 INNOVATION DRIVE
RP-2138
WAUWATOSA,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/04/2011
Decision Date 07/22/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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