FDA 510(k)

赤外線体温計、モデル：IR8807

K番号: K223037 · 2023-07-21

申請者Shen Zhen Rong Feng Technology Co., Ltd.

決定日2023-07-21

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 Thermometer, Model: IR8807 is the device name listed in this FDA 510(k) record. The listed applicant is Shen Zhen Rong Feng Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K223037. 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 Thermometer, Model: IR8807?

Infrared Thermometer, Model: IR8807 is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Shen Zhen Rong Feng Technology Co., Ltd.. The 510(k) number is K223037.

When did Infrared Thermometer, Model: IR8807 receive FDA 510(k) clearance?

Infrared Thermometer, Model: IR8807 received FDA 510(k) clearance on 2023-07-21, under 510(k) number K223037.

Who is the listed applicant for Infrared Thermometer, Model: IR8807?

The FDA 510(k) record lists Shen Zhen Rong Feng Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer, Model: IR8807?

The FDA product code for Infrared Thermometer, Model: IR8807 is FLL.

申請者としてShen Zhen Rong Feng Technology Co., Ltd.を記載するその他の記録

K223044デジタル体温計（モデルQT001）

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