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FDA 510(k)

Microlife 電子紅外線額頭溫度計，型號 FR1MN1-1

K 號：K161728 · 2016-12-05

申請人Microfile Intellectual Property GmbH
決定日期2016-12-05
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

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is the device name listed in this FDA 510(k) record. The listed applicant is Microfile Intellectual Property GmbH. It received FDA 510(k) clearance on 2016-12-05 under 510(k) number K161728. 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 Digital Infrared Forehead Thermometer, Model FR1MN1-1?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is a medical device that received FDA 510(k) clearance on 2016-12-05. The listed applicant is Microfile Intellectual Property GmbH. The 510(k) number is K161728.

When did Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 receive FDA 510(k) clearance?

Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 received FDA 510(k) clearance on 2016-12-05, under 510(k) number K161728.

Who is the listed applicant for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

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

What is the FDA product code for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1?

The FDA product code for Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 is FLL.

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