FDA 510(k)

Enbio PRO

K 號：K260254 · 2026-02-26

決定日期2026-02-26

產品代碼FLE

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Enbio PRO is the device name listed in this FDA 510(k) record. The listed applicant is Enbio Group AG. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K260254. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enbio PRO?

Enbio PRO is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Enbio Group AG. The 510(k) number is K260254.

When did Enbio PRO receive FDA 510(k) clearance?

Enbio PRO received FDA 510(k) clearance on 2026-02-26, under 510(k) number K260254.

Who is the listed applicant for Enbio PRO?

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

What is the FDA product code for Enbio PRO?

The FDA product code for Enbio PRO is FLE.

其他以 Enbio Group AG 為申請人之記錄

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。

K213991Enbio S K210279Enbio S

相關器械（代碼：FLE）

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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