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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 K141720
Device Name iuStar300 Medical Ultrasound Diagnostic System
Applicant
United Imaging Systems (Beijing) Co., Ltd.
6840 SW 45th Ln Unit 5
Miami,  FL  33155
Applicant Contact JUN PENG
Correspondent
United Imaging Systems (Beijing) Co., Ltd.
6840 SW 45th Ln Unit 5
Miami,  FL  33155
Correspondent Contact JUN PENG
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received06/25/2014
Decision Date 07/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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