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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 K231989
Device Name LOGIQ E10s, LOGIQ Fortis
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostic,
LLC
9900 Innovation Dr
Wauwatosa,  WI  53226
Applicant Contact Bryan Behn
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostic,
LLC
9900 Innovation Dr
Wauwatosa,  WI  53226
Correspondent Contact Bryan Behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/05/2023
Decision Date 11/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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