FDA 510(k)

赤外線体温計：モデルYJ600

K番号: K232473 · 2024-02-09

申請者Zhuhai Yueja Medical Device Technology Co., Ltd.

決定日2024-02-09

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 YJ600 is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K232473. 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 YJ600?

Infrared Thermometer: Model YJ600 is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. The 510(k) number is K232473.

When did Infrared Thermometer: Model YJ600 receive FDA 510(k) clearance?

Infrared Thermometer: Model YJ600 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K232473.

Who is the listed applicant for Infrared Thermometer: Model YJ600?

The FDA 510(k) record lists Zhuhai Yueja Medical Device 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 YJ600?

The FDA product code for Infrared Thermometer: Model YJ600 is FLL.

申請者としてZhuhai Yueja Medical Device Technology Co., Ltd.を記載するその他の記録

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