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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 K202658
Device Name Vivid E80/ Vivid E90/ Vivid E95
Applicant
Ge Medical Systems Ultrasound and Primary Care Diagnostics
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Tracey Ortiz
Correspondent
Ge Medical Systems Ultrasound and Primary Care Diagnostics
9900 W Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Tracey Ortiz
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ  
Date Received09/14/2020
Decision Date 03/05/2021
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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