FDA 510(k)

Advocate 非接觸遠紅外線溫度計

K 號：K191004 · 2019-09-05

決定日期2019-09-05

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

Advocate Non-Contact Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Broadmaster Biotech, Corp.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K191004. 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 Advocate Non-Contact Infrared Thermometer?

Advocate Non-Contact Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Broadmaster Biotech, Corp.. The 510(k) number is K191004.

When did Advocate Non-Contact Infrared Thermometer receive FDA 510(k) clearance?

Advocate Non-Contact Infrared Thermometer received FDA 510(k) clearance on 2019-09-05, under 510(k) number K191004.

Who is the listed applicant for Advocate Non-Contact Infrared Thermometer?

The FDA 510(k) record lists Broadmaster Biotech, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advocate Non-Contact Infrared Thermometer?

The FDA product code for Advocate Non-Contact Infrared Thermometer is FLL.

其他以 Broadmaster Biotech, Corp. 為申請人之記錄

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K180355Advocate 非接觸遠紅外線溫度計

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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