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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 K181685
Device Name Vivid E80, Vivid E90, Vivid E95
Applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics,
LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
GE Medical Systems Ultrasound and Primary Care Diagnostics,
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/26/2018
Decision Date 10/25/2018
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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