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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 K220848
Device Name Venue Fit
Applicant
GE Medical Systems
Ultrasound and Primary Care Diagnoistics, LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Lee Bush
Correspondent
GE Medical Systems
Ultrasound and Primary Care Diagnoistics, LLC
9900 W. Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Lee Bush
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/23/2022
Decision Date 06/27/2022
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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