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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 K152567
Device Name Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System
Applicant
GE Healthcare
3114 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Ayesha Pergadia
Correspondent
GE Healthcare
3114 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Ayesha Pergadia
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received09/09/2015
Decision Date 11/06/2015
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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