FDA 510(k)

溫度探針

K 號：K173194 · 2018-10-10

決定日期2018-10-10

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

Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2018-10-10 under 510(k) number K173194. 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 Temperature Probe?

Temperature Probe is a medical device that received FDA 510(k) clearance on 2018-10-10. The listed applicant is Orantech, Inc.. The 510(k) number is K173194.

When did Temperature Probe receive FDA 510(k) clearance?

Temperature Probe received FDA 510(k) clearance on 2018-10-10, under 510(k) number K173194.

Who is the listed applicant for Temperature Probe?

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

What is the FDA product code for Temperature Probe?

The FDA product code for Temperature Probe is FLL.

其他以 Orantech, Inc. 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。

K182327病人電纜及導線，一次性心電圖導線 K181270一次性SpO2感測器，可重用SpO2感測器 K173197可重用式NIBP袖帶 K171828ETCO2感測器

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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