FDA 510(k)

Neo 先進軟體

K 號：K230195 · 2024-03-08

決定日期2024-03-08

產品代碼OLO

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

Neo ADVISE software is the device name listed in this FDA 510(k) record. The listed applicant is Comerge AG. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K230195. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Neo ADVISE software?

Neo ADVISE software is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Comerge AG. The 510(k) number is K230195.

When did Neo ADVISE software receive FDA 510(k) clearance?

Neo ADVISE software received FDA 510(k) clearance on 2024-03-08, under 510(k) number K230195.

Who is the listed applicant for Neo ADVISE software?

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

What is the FDA product code for Neo ADVISE software?

The FDA product code for Neo ADVISE software is OLO.

其他以 Comerge AG 為申請人之記錄

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K252104T1D1

相關器械（代碼：OLO）

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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