生命徵象監測感測器（型號：XK300）
K 號：K202464 · 2021-04-26
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器材摘要
Vital Sign Monitoring Sensor (Model :XK300) is the device name listed in this FDA 510(k) record. The listed applicant is Xandar Kardian, Inc.. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K202464. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Vital Sign Monitoring Sensor (Model :XK300)?
Vital Sign Monitoring Sensor (Model :XK300) is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is Xandar Kardian, Inc.. The 510(k) number is K202464.
When did Vital Sign Monitoring Sensor (Model :XK300) receive FDA 510(k) clearance?
Vital Sign Monitoring Sensor (Model :XK300) received FDA 510(k) clearance on 2021-04-26, under 510(k) number K202464.
Who is the listed applicant for Vital Sign Monitoring Sensor (Model :XK300)?
The FDA 510(k) record lists Xandar Kardian, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vital Sign Monitoring Sensor (Model :XK300)?
The FDA product code for Vital Sign Monitoring Sensor (Model :XK300) is DRT.
相關臨床試驗
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相關器械（代碼：DRT）
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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