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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 K202683
Device Name ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elit
Applicant
Siemens Medical Solutions, USA, Inc.
22010 S.E. 51st Street
Issaquah,  WA  98029
Applicant Contact Christine Dunbar
Correspondent
Siemens Medical Solutions, USA, Inc.
22010 South East 51st Street
Issaquah,  WA  98029
Correspondent Contact Christine Dunbar
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ   OBJ   OIJ  
Date Received09/15/2020
Decision Date 10/15/2020
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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