FDA 510(k)

紅外線額頭體溫計

K 號：K190984 · 2020-04-22

決定日期2020-04-22

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 is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Ants Bro Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-04-22 under 510(k) number K190984. 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?

Infrared Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-04-22. The listed applicant is Xiamen Ants Bro Technology Co., Ltd.. The 510(k) number is K190984.

When did Infrared Forehead Thermometer receive FDA 510(k) clearance?

Infrared Forehead Thermometer received FDA 510(k) clearance on 2020-04-22, under 510(k) number K190984.

Who is the listed applicant for Infrared Forehead Thermometer?

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

What is the FDA product code for Infrared Forehead Thermometer?

The FDA product code for Infrared Forehead Thermometer is FLL.

其他以 Xiamen Ants Bro Technology Co., Ltd. 為申請人之記錄

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。

K190982自動數位血壓監測儀 K190990數位體溫計

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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