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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 K200644
Device Name ACUSON Freestyle Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact Shruti Arora
Correspondent
Siemens Medical Solutions USA, Inc
685 East Middlefield Road
Mountain View,  CA  94043
Correspondent Contact Shruti Arora
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/11/2020
Decision Date 04/10/2020
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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