FDA 510(k)

非接触式額頭体温計（モデルUT306HおよびUT308H）

K番号: K203747 · 2021-01-25

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

決定日2021-01-25

製品コードFLL

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Non-Contact Forehead Thermometer (Models UT306H & UT308H) 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 2021-01-25 under 510(k) number K203747. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) is a medical device that received FDA 510(k) clearance on 2021-01-25. The listed applicant is Uni-Trend Technology (China) Co., Ltd.. The 510(k) number is K203747.

When did Non-Contact Forehead Thermometer (Models UT306H & UT308H) receive FDA 510(k) clearance?

Non-Contact Forehead Thermometer (Models UT306H & UT308H) received FDA 510(k) clearance on 2021-01-25, under 510(k) number K203747.

Who is the listed applicant for Non-Contact Forehead Thermometer (Models UT306H & UT308H)?

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 (Models UT306H & UT308H)?

The FDA product code for Non-Contact Forehead Thermometer (Models UT306H & UT308H) is FLL.

申請者としてUni-Trend Technology (China) Co., Ltd.を記載するその他の記録

K203656非接触式額頭体温計（UT30H）

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