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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 K213487
Device Name ACUSON P500 Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc.
22010 S.E. 51st Street
Issaquah,  WA  98029
Applicant Contact Sulgue Choi
Correspondent
Siemens Medical Solutions USA, Inc.
22010 S.E. 51st Street
Issaquah,  WA  98029
Correspondent Contact Sulgue Choi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   OIJ  
Date Received10/29/2021
Decision Date 02/11/2022
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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