FDA 510(k)

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K 號：K203518 · 2021-03-09

申請人Omniscient Neurotechnology Pty Ltd (O8t)

決定日期2021-03-09

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Quicktome is the device name listed in this FDA 510(k) record. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). It received FDA 510(k) clearance on 2021-03-09 under 510(k) number K203518. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quicktome?

Quicktome is a medical device that received FDA 510(k) clearance on 2021-03-09. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K203518.

When did Quicktome receive FDA 510(k) clearance?

Quicktome received FDA 510(k) clearance on 2021-03-09, under 510(k) number K203518.

Who is the listed applicant for Quicktome?

The FDA 510(k) record lists Omniscient Neurotechnology Pty Ltd (O8t) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quicktome?

The FDA product code for Quicktome is LLZ.

其他以 Omniscient Neurotechnology Pty Ltd (O8t) 為申請人之記錄

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K222359Quicktome 軟體套件

相關器械（代碼：LLZ）

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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