FDA 510(k)

Quicktome 軟體套件

K 號：K222359 · 2023-05-30

申請人Omniscient Neurotechnology Pty Ltd (O8t)

決定日期2023-05-30

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Quicktome Software Suite 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 2023-05-30 under 510(k) number K222359. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

什麼是Quicktome軟體套件？

Quicktome Software Suite is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Omniscient Neurotechnology Pty Ltd (O8t). The 510(k) number is K222359.

Quicktome Software Suite於何時獲得FDA 510(k)許可？

Quicktome Software Suite received FDA 510(k) clearance on 2023-05-30, under 510(k) number K222359.

誰是Quicktome軟體套件的列名申請人？

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

FDA產品代碼是什麼？Quicktome Software Suite的FDA產品代碼是什麼？

The FDA product code for Quicktome Software Suite is LLZ.

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

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K203518Quicktome 注意：此翻譯僅根據您提供的指示進行，並保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。

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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