FDA 510(k)

赤外線額温計、モデルLFR30B、LFR50、LFR60

K番号: K202687 · 2021-02-18

申請者Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

決定日2021-02-18

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

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-02-18 under 510(k) number K202687. 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 Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60?

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is a medical device that received FDA 510(k) clearance on 2021-02-18. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K202687.

When did Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 received FDA 510(k) clearance on 2021-02-18, under 510(k) number K202687.

Who is the listed applicant for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60?

The FDA 510(k) record lists Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60?

The FDA product code for Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 is FLL.

申請者としてShenzhen Lepu Intelligent Medical Equipment Co., Ltd.を記載するその他の記録

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