FDA 510(k)

Microlife Digital Infrared Ear Thermometer

K 號：K183663 · 2019-07-16

決定日期2019-07-16

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 Ear Thermometer 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 2019-07-16 under 510(k) number K183663. 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 Ear Thermometer?

Microlife Digital Infrared Ear Thermometer is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K183663.

When did Microlife Digital Infrared Ear Thermometer receive FDA 510(k) clearance?

Microlife Digital Infrared Ear Thermometer received FDA 510(k) clearance on 2019-07-16, under 510(k) number K183663.

Who is the listed applicant for Microlife Digital Infrared Ear Thermometer?

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 Digital Infrared Ear Thermometer?

The FDA product code for Microlife Digital Infrared Ear Thermometer is FLL.

其他以 Microlife Intellectual Property GmbH 為申請人之記錄

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。

K230075麥可萊上臂自動數字血壓監測器，型號 BP3KVl-5K K222979麥可萊上臂自動數字血壓監測器，型號 BP3KV1-5W K222153麥可萊上臂自動數字脈搏血壓計，型號 WatchBP Office 腕動脈（TWIN200 VSR）K211776麥可萊非接觸式紅外線額頭溫度計，型號FR1MF1-B（NC150 BT）K211288Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B K202729麥可萊上臂自動數字血壓監測器

查看所有 18 項裝置 →

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。

K253162溫度探針（T2252-PG）；溫度探針（TCMA-AG）；溫度探針（TCMA-PG）；溫度探針（TMQ-DAG）；溫度探針（THP-DAG）Unimed Medical Supplies, Inc.K251160無菌溫度探針（型號：W0001ES、W0028ES、W0101FS-A、W0101FS-P、W0099LS、W0099FS、W0099PS）Shenzhen Med-Link Electronics Tech Co., Ltd.K250470耳溫計（EAR-E101）；耳溫計（EAR-E102）；耳溫計（EAR-E103）Shenzhen AOJ Medical Technology Co., Ltd.K243000可重用溫度探針（T1306、T2306、T3306、T4306）；一次性溫度探針（T5106、T6106）Shenzhen Medke Technology Co., Ltd.K250878YUWELL® 紅外線耳溫計（YHT100）；YUWELL® 紅外線耳溫計（YHT107）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082紅外線體溫計Guangzhou Daxin Health Technology Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。