FDA 510(k)

非接触型電子額頭赤外線体温計

K番号: K201582 · 2021-01-15

申請者Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.

決定日2021-01-15

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 Electronic Forehead Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201582. 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 Electronic Forehead Infrared Thermometer?

Non-contact Electronic Forehead Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.. The 510(k) number is K201582.

When did Non-contact Electronic Forehead Infrared Thermometer receive FDA 510(k) clearance?

Non-contact Electronic Forehead Infrared Thermometer received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201582.

Who is the listed applicant for Non-contact Electronic Forehead Infrared Thermometer?

The FDA 510(k) record lists Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Electronic Forehead Infrared Thermometer?

The FDA product code for Non-contact Electronic Forehead Infrared Thermometer is FLL.

申請者としてZhongshan Jinli Electronic Weighing Equipment Co., Ltd.を記載するその他の記録

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