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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 K072075
Device Name MODIFICATION TO GE LOGIQ A3
Applicant
GENERAL ELECTRIC CO.
9900 INNOVATION DRIVE
MAIL CODE: RP-2138
WAUWATOSA,  WI  53226
Applicant Contact ALLEN SCHUH
Correspondent
GENERAL ELECTRIC CO.
9900 INNOVATION DRIVE
MAIL CODE: RP-2138
WAUWATOSA,  WI  53226
Correspondent Contact ALLEN SCHUH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/30/2007
Decision Date 08/29/2007
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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