FDA 510(k)

麥可萊非接觸式紅外線額頭溫度計，型號FR1MF1-B（NC150 BT）

K 號：K211776 · 2022-03-01

決定日期2022-03-01

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

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K211776. 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 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K211776.

When did Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) receive FDA 510(k) clearance?

Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) received FDA 510(k) clearance on 2022-03-01, under 510(k) number K211776.

Who is the listed applicant for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)?

The FDA product code for Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is FLL.

其他以 Microlife Intellectual Property GmbH 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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官方來源

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