FDA 510(k)

紅外耳溫計

K 號：K180387 · 2019-01-10

決定日期2019-01-10

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 Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K180387. 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 Thermometer?

Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K180387.

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

Infrared Ear Thermometer received FDA 510(k) clearance on 2019-01-10, under 510(k) number K180387.

Who is the listed applicant for Infrared Ear Thermometer?

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

What is the FDA product code for Infrared Ear Thermometer?

The FDA product code for Infrared Ear Thermometer is FLL.

其他以 Hetaida 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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