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FDA 510(k)

Q-Pad測試系統

K 號：K231465 · 2023-12-06

申請人Qurasense
決定日期2023-12-06
產品代碼LCP
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Q-Pad Test System is the device name listed in this FDA 510(k) record. The listed applicant is Qurasense. It received FDA 510(k) clearance on 2023-12-06 under 510(k) number K231465. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q-Pad Test System?

Q-Pad Test System is a medical device that received FDA 510(k) clearance on 2023-12-06. The listed applicant is Qurasense. The 510(k) number is K231465.

When did Q-Pad Test System receive FDA 510(k) clearance?

Q-Pad Test System received FDA 510(k) clearance on 2023-12-06, under 510(k) number K231465.

Who is the listed applicant for Q-Pad Test System?

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

What is the FDA product code for Q-Pad Test System?

The FDA product code for Q-Pad Test System is LCP.

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。

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相關器械（代碼：LCP）

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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官方來源

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