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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 K162269
Device Name Voluson E6, Voluson E8, Voluson E10
Applicant
GE Healthcare
9900 Innovation Drive,
Milwaukee County Research Park
Wauwatosa,  WI  53226
Applicant Contact Bryan Behn
Correspondent
GE Healthcare
9900 Innovation Drive,
Milwaukee County Research Park
Wauwatosa,  WI  53226
Correspondent Contact Bryan Behn
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/12/2016
Decision Date 10/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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