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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 K061129
Device Name GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000
Applicant
GENERAL ELECTRIC CO.
99000 INNOVATION DRIVE
WAUWATOSA,  WI  53226
Applicant Contact PATRICIA TAIGE
Correspondent
GENERAL ELECTRIC CO.
99000 INNOVATION DRIVE
WAUWATOSA,  WI  53226
Correspondent Contact PATRICIA TAIGE
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/24/2006
Decision Date 06/01/2006
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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