VisioFocus Mini, VisioFocus 智能型
K 號：K160680 · 2017-04-19
廣告
決定日期2017-04-19
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
VisioFocus Mini, VisioFocus Smart is the device name listed in this FDA 510(k) record. The listed applicant is Tecnimed S.R.L.. It received FDA 510(k) clearance on 2017-04-19 under 510(k) number K160680. 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 VisioFocus Mini, VisioFocus Smart?
VisioFocus Mini, VisioFocus Smart is a medical device that received FDA 510(k) clearance on 2017-04-19. The listed applicant is Tecnimed S.R.L.. The 510(k) number is K160680.
When did VisioFocus Mini, VisioFocus Smart receive FDA 510(k) clearance?
VisioFocus Mini, VisioFocus Smart received FDA 510(k) clearance on 2017-04-19, under 510(k) number K160680.
Who is the listed applicant for VisioFocus Mini, VisioFocus Smart?
The FDA 510(k) record lists Tecnimed S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VisioFocus Mini, VisioFocus Smart?
The FDA product code for VisioFocus Mini, VisioFocus Smart 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