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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 K221190
Device Name ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc.
22010 South East 51st Street
Issaquah,  WA  98029
Applicant Contact Sulgue Choi
Correspondent
Siemens Medical Solutions USA, Inc.
22010 South East 51st Street
Issaquah,  WA  98029
Correspondent Contact Sulgue Choi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OIJ  
Date Received04/25/2022
Decision Date 08/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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