FDA 510(k)

QP-Brain®

K 號：K232231 · 2023-12-13

決定日期2023-12-13

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

QP-Brain® is the device name listed in this FDA 510(k) record. The listed applicant is Quibim S.L.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K232231. 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 QP-Brain®?

QP-Brain® is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Quibim S.L.. The 510(k) number is K232231.

When did QP-Brain® receive FDA 510(k) clearance?

QP-Brain® received FDA 510(k) clearance on 2023-12-13, under 510(k) number K232231.

Who is the listed applicant for QP-Brain®?

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

What is the FDA product code for QP-Brain®?

The FDA product code for QP-Brain® is QIH.

其他以 Quibim S.L. 為申請人之記錄

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相關器械（代碼：QIH）

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官方來源

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