FDA 510(k)

紅外線額頭溫度計 LD-FT-100B

K 號：K211629 · 2021-12-08

決定日期2021-12-08

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

Infrared forehead thermometer LD-FT-100B is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K211629. 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 Infrared forehead thermometer LD-FT-100B?

Infrared forehead thermometer LD-FT-100B is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K211629.

When did Infrared forehead thermometer LD-FT-100B receive FDA 510(k) clearance?

Infrared forehead thermometer LD-FT-100B received FDA 510(k) clearance on 2021-12-08, under 510(k) number K211629.

Who is the listed applicant for Infrared forehead thermometer LD-FT-100B?

FDA 510(k) 記錄將宏遠（南通）有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Infrared forehead thermometer LD-FT-100B?

The FDA product code for Infrared forehead thermometer LD-FT-100B is FLL.

其他以 Honsun (Nantong) 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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官方來源

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