FDA 510(k)

CIRCA MATRIX12 M 食管溫度探針及溫度監測系統

K 號：K222311 · 2023-05-25

決定日期2023-05-25

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

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K222311. 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 CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K222311.

When did CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System receive FDA 510(k) clearance?

CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System received FDA 510(k) clearance on 2023-05-25, under 510(k) number K222311.

Who is the listed applicant for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

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

What is the FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System?

The FDA product code for CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System is FLL.

其他以 Circa Scientific, 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。

K251007CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）K243954PeriCross™ 心外膜進入套件 K243193Cross Wise™ 多功能RF轉接線 K241414CrossWise RF 腦室進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C）；CrossWise RF 适配器電纜（型號 CW-1002）K240004CardioCurve 可導導管小彎曲，40cm (CC-1040S)；CardioCurve 可導導管中彎曲，40cm (CC-1040M)；CardioCurve 可導導管大彎曲，40cm (CC-1040L)；CardioCurve 可導導管小彎曲，61cm (CC-1061S)；CardioCurve 可導導管中彎曲，61cm (CC-1061M)；CardioCurve 可導導管大彎曲，61cm (CC-1061L)；CardioCurve 可導導管小彎曲，71cm (CC-1071S)；CardioCurve 可導導管中彎曲，71cm (CC-1071M)；CardioCurve Steer

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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