e-Celsius醫療系統
K 號：K210924 · 2023-06-28
廣告
申請人Bodycap
決定日期2023-06-28
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
e-Celsius Medical System is the device name listed in this FDA 510(k) record. The listed applicant is Bodycap. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K210924. 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 e-Celsius Medical System?
e-Celsius Medical System is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Bodycap. The 510(k) number is K210924.
When did e-Celsius Medical System receive FDA 510(k) clearance?
e-Celsius Medical System received FDA 510(k) clearance on 2023-06-28, under 510(k) number K210924.
Who is the listed applicant for e-Celsius Medical System?
The FDA 510(k) record lists Bodycap as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for e-Celsius Medical System?
The FDA product code for e-Celsius Medical System is FLL.
相關臨床試驗
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。
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。
廣告