FDA 510(k)

紅外線額頭溫度計，紅外線耳/額頭溫度計

K 號：K181239 · 2018-10-29

決定日期2018-10-29

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, 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 2018-10-29 under 510(k) number K181239. 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 Ear/Forehead Thermometer?

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-10-29. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K181239.

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

Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer received FDA 510(k) clearance on 2018-10-29, under 510(k) number K181239.

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

The FDA product code for Infrared Forehead Thermometer, 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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