FDA 510(k)

デジタル体温計、モデルT28、T28L

K番号: K232678 · 2024-01-31

申請者Guangdong Genial Technology Co., Ltd.

決定日2024-01-31

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

Digital Thermometer, Model T28, T28L is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Genial Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K232678. 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 Digital Thermometer, Model T28, T28L?

Digital Thermometer, Model T28, T28L is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Guangdong Genial Technology Co., Ltd.. The 510(k) number is K232678.

When did Digital Thermometer, Model T28, T28L receive FDA 510(k) clearance?

Digital Thermometer, Model T28, T28L received FDA 510(k) clearance on 2024-01-31, under 510(k) number K232678.

Who is the listed applicant for Digital Thermometer, Model T28, T28L?

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

What is the FDA product code for Digital Thermometer, Model T28, T28L?

The FDA product code for Digital Thermometer, Model T28, T28L is FLL.

申請者としてGuangdong Genial Technology Co., Ltd.を記載するその他の記録

K240333ウェアラブルデジタル体温計（T31）K231250デジタル血圧計 K231245デジタル血圧計（腕型）K231243指先型血中酸素濃度計

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