FDA 510(k)

腦行Go Plus

K 號：K213986 · 2023-04-13

決定日期2023-04-13

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

CerebralGo Plus is the device name listed in this FDA 510(k) record. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K213986. 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 CerebralGo Plus?

CerebralGo Plus is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Yukun (Beijing) Technology Co., Ltd.. The 510(k) number is K213986.

When did CerebralGo Plus receive FDA 510(k) clearance?

CerebralGo Plus received FDA 510(k) clearance on 2023-04-13, under 510(k) number K213986.

Who is the listed applicant for CerebralGo Plus?

The FDA 510(k) record lists Yukun (Beijing) Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CerebralGo Plus?

The FDA product code for CerebralGo Plus is QIH.

其他以 Yukun (Beijing) Technology Co., Ltd. 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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