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FDA 510(k)

非接觸紅外線體溫計（型號：WL-301、WL-501、WL-601、WL-701）

K 號：K210171 · 2022-03-18

申請人Sichuan Youkede Medical Equipment Co.,Ltd
決定日期2022-03-18
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

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Youkede Medical Equipment Co.,Ltd. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K210171. 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 Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)?

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Sichuan Youkede Medical Equipment Co.,Ltd. The 510(k) number is K210171.

When did Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) receive FDA 510(k) clearance?

Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) received FDA 510(k) clearance on 2022-03-18, under 510(k) number K210171.

Who is the listed applicant for Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)?

The FDA 510(k) record lists Sichuan Youkede Medical Equipment Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)?

The FDA product code for Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is FLL.

相關臨床試驗

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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