FDA 510(k)

Celsi 監視器

K 號：K230298 · 2023-08-16

決定日期2023-08-16

產品代碼FLL

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

Celsi Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Hadleigh Health Technologies. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230298. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Celsi Monitor?

Celsi Monitor is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Hadleigh Health Technologies. The 510(k) number is K230298.

When did Celsi Monitor receive FDA 510(k) clearance?

Celsi Monitor received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230298.

Who is the listed applicant for Celsi Monitor?

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

What is the FDA product code for Celsi Monitor?

The FDA product code for Celsi Monitor is FLL.

其他以 Hadleigh Health Technologies 為申請人之記錄

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K242964Celsi 加熱器

相關器械（代碼：FLL）

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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