FDA 510(k)

非觸碰額頭式體溫計 (TH48FE, TH09F, THD2FE)

K 號：K240648 · 2024-06-05

決定日期2024-06-05

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

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2024-06-05 under 510(k) number K240648. 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 Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is a medical device that received FDA 510(k) clearance on 2024-06-05. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K240648.

When did Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) receive FDA 510(k) clearance?

Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) received FDA 510(k) clearance on 2024-06-05, under 510(k) number K240648.

Who is the listed applicant for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

The FDA 510(k) record lists Radiant Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)?

The FDA product code for Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) is FLL.

其他以 Radiant Innovation, Inc. 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。

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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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