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FDA 510(k)

紅外線額頭溫度計（型號：T80、T81、T82、T83、T84、T85）

K 號：K210014 · 2021-06-04

申請人Guandong Genial Technology Co., Limited
決定日期2021-06-04
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

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is the device name listed in this FDA 510(k) record. The listed applicant is Guandong Genial Technology Co., Limited. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K210014. 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 Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Guandong Genial Technology Co., Limited. The 510(k) number is K210014.

When did Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) receive FDA 510(k) clearance?

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) received FDA 510(k) clearance on 2021-06-04, under 510(k) number K210014.

Who is the listed applicant for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA 510(k) record lists Guandong Genial Technology Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)?

The FDA product code for Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) is FLL.

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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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