FDA 510(k)

數位體溫計，型號 T28，T28L

K 號：K232678 · 2024-01-31

申請人Guangdong Genial Technology Co., Ltd.

決定日期2024-01-31

產品代碼FLL

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Guangdong Genial Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：FLL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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