FDA 510(k)

紅外線體溫計（型號：Y20001、Y20002）

K 號：K221800 · 2022-12-14

申請人Zhangzhou Easepal Medical Science and Technology Co., Ltd.

決定日期2022-12-14

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

Infrared Thermometer (Model: Y20001, Y20002) is the device name listed in this FDA 510(k) record. The listed applicant is Zhangzhou Easepal Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K221800. 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 Infrared Thermometer (Model: Y20001, Y20002)?

Infrared Thermometer (Model: Y20001, Y20002) is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Zhangzhou Easepal Medical Science and Technology Co., Ltd.. The 510(k) number is K221800.

When did Infrared Thermometer (Model: Y20001, Y20002) receive FDA 510(k) clearance?

Infrared Thermometer (Model: Y20001, Y20002) received FDA 510(k) clearance on 2022-12-14, under 510(k) number K221800.

Who is the listed applicant for Infrared Thermometer (Model: Y20001, Y20002)?

The FDA 510(k) record lists Zhangzhou Easepal Medical Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer (Model: Y20001, Y20002)?

The FDA product code for Infrared Thermometer (Model: Y20001, Y20002) is FLL.

其他以 Zhangzhou Easepal Medical Science and Technology Co., Ltd. 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。

K240373空氣壓縮腿部按摩器（MM0520，MM0521，MM0522）K213023血壓監測器（型號：Y30001）

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。