FDA 510(k)

SonoEye P3/ SonoEye V3/ Sono Eye G3 電子彩色多普勒掌上式超音波系統

K 號：K201968 · 2021-02-26

申請人CHISON Medical Technologies Co., Ltd.

決定日期2021-02-26

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is CHISON Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) number K201968. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System?

SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System is a medical device that received FDA 510(k) clearance on 2021-02-26. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K201968.

When did SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System receive FDA 510(k) clearance?

SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System received FDA 510(k) clearance on 2021-02-26, under 510(k) number K201968.

Who is the listed applicant for SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System?

The FDA 510(k) record lists CHISON Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System?

The FDA product code for SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System is IYN.

其他以 CHISON Medical Technologies Co., Ltd. 為申請人之記錄

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K253949SonoPort系列數字彩色多普勒超聲系統（SonoPort 1、SonoPort 1 Exp、SonoPort 1 Pro、SonoPort 1 Elite、SonoPort 1 Plus、SonoPort 2、SonoPort 2 Exp、SonoPort 2 Pro、SonoPort 2 Elite、SonoPort 2 Plus、SonoPort 3、SonoPort 3 Exp、SonoPort 3 Pro、SonoPort 3 Elite、SonoPort 3 Plus、SonoPort 4、SonoPort 4 Exp、SonoPort 4 Pro、SonoPort 4 Elite、SonoPort 4 Plus、SonoPort 5、SonoPort 5 Exp、SonoPort 5 Pro、SonoPort 5 Elite、SonoPort 5 Plus、SonoPort 6、SonoPort 6 Exp、SonoPort 6）K233697SonoMax系列數字顏色多普勒超聲系統 K223570SonoAir系列數字顏色多普勒超聲系統 K202457M1外科口罩 K201965SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G 電子顏色多普勒掌上超音波系統 K201967SonoEye P2/ SonoEye V2/ SonoEye G2 電子彩色多普勒掌上式超音波系統

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相關器械（代碼：IYN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

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