FDA 510(k)

XBit系列數字顏色多普勒超聲系統

K 號：K200780 · 2020-08-05

申請人CHISON Medical Technologies Co., Ltd.

決定日期2020-08-05

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

XBit Series Digital Color Doppler 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 2020-08-05 under 510(k) number K200780. 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 XBit Series Digital Color Doppler Ultrasound System?

XBit Series Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is CHISON Medical Technologies Co., Ltd.. The 510(k) number is K200780.

When did XBit Series Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

XBit Series Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2020-08-05, under 510(k) number K200780.

Who is the listed applicant for XBit Series Digital Color Doppler 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 XBit Series Digital Color Doppler Ultrasound System?

The FDA product code for XBit Series Digital Color Doppler Ultrasound System is IYN.

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

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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。

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