FDA 510(k)

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K 號：K192753 · 2020-03-17

決定日期2020-03-17

產品代碼GWQ

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

NeuralScan System is the device name listed in this FDA 510(k) record. The listed applicant is Medeia, Inc.. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K192753. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeuralScan System?

NeuralScan System is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Medeia, Inc.. The 510(k) number is K192753.

When did NeuralScan System receive FDA 510(k) clearance?

NeuralScan System received FDA 510(k) clearance on 2020-03-17, under 510(k) number K192753.

Who is the listed applicant for NeuralScan System?

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 NeuralScan System?

The FDA product code for NeuralScan System is GWQ.

其他以 Medeia, Inc. 為申請人之記錄

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相關器械（代碼：GWQ）

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