FDA 510(k)

AT-6XX 系列紅外線溫度計

K 號：K171455 · 2018-02-09

決定日期2018-02-09

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

AT-6XX Series Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K171455. 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 AT-6XX Series Infrared Thermometer?

AT-6XX Series Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. The 510(k) number is K171455.

When did AT-6XX Series Infrared Thermometer receive FDA 510(k) clearance?

AT-6XX Series Infrared Thermometer received FDA 510(k) clearance on 2018-02-09, under 510(k) number K171455.

Who is the listed applicant for AT-6XX Series Infrared Thermometer?

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

What is the FDA product code for AT-6XX Series Infrared Thermometer?

The FDA product code for AT-6XX Series Infrared Thermometer is FLL.

其他以 Xiamen Acurio Instruments Co., Ltd. 為申請人之記錄

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K180685AS-3XX系列指端血氧濃度計

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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