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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 K211321
Device Name Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Applicant
Guangzhou Sonostar Technologies Co., Ltd.
504#, C Bldg.,#27 Yayingshi Rd., Science Town
Guangzhou,  CN 510665
Applicant Contact Weizhong Cai
Correspondent
Guangzhou Sonostar Technologies Co., Ltd.
504#, C Bldg.,#27 Yayingshi Rd., Science Town
Guangzhou,  CN 510665
Correspondent Contact Weizhong Cai
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/30/2021
Decision Date 10/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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