FDA 510(k)

VBrain-OAR

K 號：K212116 · 2021-10-12

決定日期2021-10-12

產品代碼QKB

諮詢委員會RA

決定相當於

器材摘要

VBrain-OAR is the device name listed in this FDA 510(k) record. The listed applicant is Vysioneer, Inc.. It received FDA 510(k) clearance on 2021-10-12 under 510(k) number K212116. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VBrain-OAR?

VBrain-OAR is a medical device that received FDA 510(k) clearance on 2021-10-12. The listed applicant is Vysioneer, Inc.. The 510(k) number is K212116.

When did VBrain-OAR receive FDA 510(k) clearance?

VBrain-OAR received FDA 510(k) clearance on 2021-10-12, under 510(k) number K212116.

Who is the listed applicant for VBrain-OAR?

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

What is the FDA product code for VBrain-OAR?

The FDA product code for VBrain-OAR is QKB.

其他以 Vysioneer, Inc. 為申請人之記錄

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。

K213628V腦 K203235V腦

相關器械（代碼：QKB）

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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