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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 K201965
Device Name SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
Applicant
Chison Medical Technologies Co., Ltd.
No.228, Changjiang East Road, Block 51 and 53, Phase 5,
Shuofang Industrial Park
wuxi,  CN 214142
Applicant Contact qifei liu
Correspondent
Chison Medical Technologies Co., Ltd.
No.228, Changjiang East Road, Block 51 and 53, Phase 5,
Shuofang Industrial Park, Xinwu District
wuxi,  CN 214142
Correspondent Contact qifei liu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/15/2020
Decision Date 03/02/2021
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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