FDA 510(k)

qER-量測器

K 號：K211222 · 2021-07-30

決定日期2021-07-30

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

qER-Quant is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211222. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the qER-Quant?

qER-Quant is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Qure.Ai Technologies. The 510(k) number is K211222.

When did qER-Quant receive FDA 510(k) clearance?

qER-Quant received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211222.

Who is the listed applicant for qER-Quant?

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

What is the FDA product code for qER-Quant?

The FDA product code for qER-Quant is QIH.

其他以 Qure.Ai Technologies 為申請人之記錄

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相關器械（代碼：QIH）

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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