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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 K133533
Device Name LOGIQ E
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 Received11/18/2013
Decision Date 02/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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