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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 echo, ultrasonic
510(k) Number K072797
Device Name GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND
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 Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received10/01/2007
Decision Date 10/17/2007
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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