SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

Chison Medical Technologies Co., Ltd.

The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for Sonoeye P1/ Sonoeye P1-g/ Sonoeye V1/ Sonoeye V1-g/ Sonoeye G1/ Sonoeye G1-g Digital Color Doppler Palm Ultrasound System.

Pre-market Notification Details

Device IDK201965
510k NumberK201965
Device Name:SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Chison Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park Wuxi,  CN 214142
ContactQifei Liu
CorrespondentQifei Liu
Chison Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi,  CN 214142
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-15
Decision Date2021-03-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945121413060 K201965 000

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