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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 K213642
Device Name Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
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 Received11/18/2021
Decision Date 01/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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