Qualisys醫學設備規範文本 Qualisys臨床系統
K 號：K171547 · 2018-08-02
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器材摘要
Qualisys Clinical System is the device name listed in this FDA 510(k) record. The listed applicant is Qualisys AB. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K171547. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Qualisys Clinical System?
Qualisys Clinical System is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Qualisys AB. The 510(k) number is K171547.
When did Qualisys Clinical System receive FDA 510(k) clearance?
Qualisys Clinical System received FDA 510(k) clearance on 2018-08-02, under 510(k) number K171547.
Who is the listed applicant for Qualisys Clinical System?
The FDA 510(k) record lists Qualisys AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Qualisys Clinical System?
The FDA product code for Qualisys Clinical System is LXJ.
相關臨床試驗
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。
相關器械（代碼：LXJ）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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