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FDA 510(k)

詢問站 TS

K 號:K153600 · 2017-03-17

申請人H4D Sas
決定日期2017-03-17
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Consult Station TS is the device name listed in this FDA 510(k) record. The listed applicant is H4D Sas. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K153600. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Consult Station TS?

Consult Station TS is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is H4D Sas. The 510(k) number is K153600.

When did Consult Station TS receive FDA 510(k) clearance?

Consult Station TS received FDA 510(k) clearance on 2017-03-17, under 510(k) number K153600.

Who is the listed applicant for Consult Station TS?

The FDA 510(k) record lists H4D Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Consult Station TS?

The FDA product code for Consult Station TS is DXN.

相關臨床試驗

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相關器械(代碼:DXN)

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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