FDA 510(k)

Mon-a-Therm™ 通用溫度探針 400TM (90050, 90044)

K 號：K240077 · 2024-08-20

決定日期2024-08-20

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

Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K240077. 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 Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)?

Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Covidien. The 510(k) number is K240077.

When did Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) receive FDA 510(k) clearance?

Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) received FDA 510(k) clearance on 2024-08-20, under 510(k) number K240077.

Who is the listed applicant for Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)?

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

What is the FDA product code for Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)?

The FDA product code for Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) is FLL.

其他以 Covidien 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。

K241486Sofsilk™ 包覆織錯絲縫線 K231934GIA™ 鋳釘器，配備 Tri-Staple™ 技術 K231240MaxTack™ 電動固定裝置 K223130Shiley™ 小兒口腔/鼻咽氣管管路配TaperGuard™ 袖，非DEHP（86125，86130，86135，86140，86145，86150，86155，86160）K232126EEA™環形釘釘器搭配Tri-Staple™技術及OrVil™口腔環形釘釘器底座 K231491TA™ 鋼釘釘書機及加載單元，配備 DST Series™ 技術

查看所有 61 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。