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FDA 510(k)

X3 Exp/X3/X3 Pro/X1 Pro/X1數位彩色多普勒超音波系統

K 號:K163427 · 2017-01-03

決定日期2017-01-03
產品代碼IYN
諮詢委員會RA
決定相當於

器材摘要

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2017-01-03 under 510(k) number K163427. 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-01-03. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K163427.

When did X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-01-03, under 510(k) number K163427.

Who is the listed applicant for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

FDA 510(k) 記錄將 Sonoscape Medical Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

The FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is IYN.

相關臨床試驗

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其他以 Sonoscape Medical Corp. 為申請人之記錄

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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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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