FDA 510(k)

非觸碰額頭式體溫計（UT30H）

K 號：K203656 · 2021-01-22

申請人Uni-Trend Technology (China) Co., Ltd.

決定日期2021-01-22

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 Thermometer (UT30H) is the device name listed in this FDA 510(k) record. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K203656. 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 Thermometer (UT30H)?

Non-Contact Forehead Thermometer (UT30H) is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203656.

When did Non-Contact Forehead Thermometer (UT30H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (UT30H) received FDA 510(k) clearance on 2021-01-22, under 510(k) number K203656.

Who is the listed applicant for Non-Contact Forehead Thermometer (UT30H)?

The FDA 510(k) record lists Uni-Trend Technology (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-Contact Forehead Thermometer (UT30H)?

The FDA product code for Non-Contact Forehead Thermometer (UT30H) is FLL.

其他以 Uni-Trend Technology (China) Co., Ltd. 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。

K203747非觸碰額頭式體溫計（型號UT306H與UT308H）

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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