FDA 510(k)

腦視覺QEEG軟體

K 號：K212684 · 2023-01-28

決定日期2023-01-28

產品代碼OLU

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

BrainView QEEG Software is the device name listed in this FDA 510(k) record. The listed applicant is Medeia, Inc.. It received FDA 510(k) clearance on 2023-01-28 under 510(k) number K212684. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BrainView QEEG Software?

BrainView QEEG Software is a medical device that received FDA 510(k) clearance on 2023-01-28. The listed applicant is Medeia, Inc.. The 510(k) number is K212684.

When did BrainView QEEG Software receive FDA 510(k) clearance?

BrainView QEEG Software received FDA 510(k) clearance on 2023-01-28, under 510(k) number K212684.

Who is the listed applicant for BrainView QEEG Software?

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

What is the FDA product code for BrainView QEEG Software?

The FDA product code for BrainView QEEG Software is OLU.

其他以 Medeia, Inc. 為申請人之記錄

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相關器械（代碼：OLU）

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官方來源

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