FDA 510(k)

數位體溫計模型 T103, T104

K 號：K201879 · 2021-03-31

決定日期2021-03-31

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

Digital Thermometer Model T103, T104 is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K201879. 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 Digital Thermometer Model T103, T104?

Digital Thermometer Model T103, T104 is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201879.

When did Digital Thermometer Model T103, T104 receive FDA 510(k) clearance?

Digital Thermometer Model T103, T104 received FDA 510(k) clearance on 2021-03-31, under 510(k) number K201879.

Who is the listed applicant for Digital Thermometer Model T103, T104?

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

What is the FDA product code for Digital Thermometer Model T103, T104?

The FDA product code for Digital Thermometer Model T103, T104 is FLL.

其他以 Bioland Technology, 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。

K202739Bioland G-425-2V 血糖監測系統，Bioland G-425-2 血糖監測系統 K213011紅外線體溫計（型號：E201）K202934血壓監測器 K201161紅外線體溫計模型 E127 K201467血壓監測器-型號 2005, 2006-2, 2006-2B K191657Bioland 血糖監測系統

查看所有 7 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。