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FDA 510(k)

追蹤 T4 腦電圖放大器

K 號:K172271 · 2018-05-04

決定日期2018-05-04
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

Trackit T4 EEG Amplifier is the device name listed in this FDA 510(k) record. The listed applicant is Lifelines , Ltd.. It received FDA 510(k) clearance on 2018-05-04 under 510(k) number K172271. 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 Trackit T4 EEG Amplifier?

Trackit T4 EEG Amplifier is a medical device that received FDA 510(k) clearance on 2018-05-04. The listed applicant is Lifelines , Ltd.. The 510(k) number is K172271.

When did Trackit T4 EEG Amplifier receive FDA 510(k) clearance?

Trackit T4 EEG Amplifier received FDA 510(k) clearance on 2018-05-04, under 510(k) number K172271.

Who is the listed applicant for Trackit T4 EEG Amplifier?

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

What is the FDA product code for Trackit T4 EEG Amplifier?

The FDA product code for Trackit T4 EEG Amplifier is GWQ.

相關臨床試驗

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相關器械(代碼:GWQ)

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。

官方來源

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