FDA 510(k)

Axonpen, Axonmonitor, Axonbox, 平板電腦

K 號：K201308 · 2020-11-27

決定日期2020-11-27

產品代碼GWG

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

Axonpen, Axonmonitor, Axonbox, Tablet is the device name listed in this FDA 510(k) record. The listed applicant is Clearmind Biomedical. It received FDA 510(k) clearance on 2020-11-27 under 510(k) number K201308. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Axonpen, Axonmonitor, Axonbox, Tablet?

Axonpen, Axonmonitor, Axonbox, Tablet is a medical device that received FDA 510(k) clearance on 2020-11-27. The listed applicant is Clearmind Biomedical. The 510(k) number is K201308.

When did Axonpen, Axonmonitor, Axonbox, Tablet receive FDA 510(k) clearance?

Axonpen, Axonmonitor, Axonbox, Tablet received FDA 510(k) clearance on 2020-11-27, under 510(k) number K201308.

Who is the listed applicant for Axonpen, Axonmonitor, Axonbox, Tablet?

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

What is the FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet?

The FDA product code for Axonpen, Axonmonitor, Axonbox, Tablet is GWG.

其他以 Clearmind Biomedical 為申請人之記錄

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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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