FDA 510(k)

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System

K-Number: K201967 · 2021-02-26

ApplicantCHISON Medical Technologies Co., Ltd.

Decision Date2021-02-26

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a medical device manufactured by CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under approval number K201967. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System?

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by CHISON Medical Technologies Co., Ltd.. The 510(k) number is K201967.

When was SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System approved by the FDA?

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System received FDA 510(k) clearance on 2021-02-26, under approval number K201967.

What company makes SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System?

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is manufactured by CHISON Medical Technologies Co., Ltd..

What is the FDA product code for SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System?

The FDA product code for SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System is IYN.

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Other Devices by CHISON Medical Technologies Co., Ltd.

K180974CBit Series Digital Color Doppler Ultrasound System K200780XBit Series Digital Color Doppler Ultrasound System K202457M1 Surgical Face Mask K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System K201968SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System K201969SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System

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Related Devices (Code: IYN)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.