FDA 510(k)

紅外耳/額頭體溫計

K 號：K190873 · 2019-07-26

決定日期2019-07-26

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 Ear/Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190873. 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 Ear/Forehead Thermometer?

Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K190873.

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

Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190873.

Who is the listed applicant for Infrared Ear/Forehead Thermometer?

FDA 510(k) 記錄將 Joytech Healthcare Co., Ltd. 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 Ear/Forehead Thermometer?

The FDA product code for Infrared Ear/Forehead Thermometer is FLL.

其他以 Joytech Healthcare 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。

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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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