FDA 510(k)

醫用設備註冊文本翻譯（zh-TW）： Med-link 體溫探針

K 號：K182667 · 2019-06-18

申請人Shenzhen Med-Link Electronics Tech Co., Ltd.

決定日期2019-06-18

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

Med-link Temperature Probes is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-18 under 510(k) number K182667. 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 Med-link Temperature Probes?

Med-link Temperature Probes is a medical device that received FDA 510(k) clearance on 2019-06-18. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K182667.

When did Med-link Temperature Probes receive FDA 510(k) clearance?

Med-link Temperature Probes received FDA 510(k) clearance on 2019-06-18, under 510(k) number K182667.

Who is the listed applicant for Med-link Temperature Probes?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Med-link Temperature Probes?

The FDA product code for Med-link Temperature Probes is FLL.

其他以 Shenzhen Med-Link Electronics Tech Co., Ltd. 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。

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

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