FDA 510(k)

CIRCA MATRIX12 M 食管温度探头和温度监控系统

K号: K222311 · 2023-05-25

决定日期2023-05-25

产品代码FLL

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Circa Scientific, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

相关器械（代码：FLL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253162温度探头 (T2252-PG)；温度探头 (TCMA-AG)；温度探头 (TCMA-PG)；温度探头 (TMQ-DAG)；温度探头 (THP-DAG)Unimed Medical Supplies, Inc.K251160无菌温度探头（型号：W0001ES，W0028ES，W0101FS-A，W0101FS-P，W0099LS，W0099FS，W0099PS）Shenzhen Med-Link Electronics Tech Co., Ltd.K250470耳温计（EAR-E101）；耳温计（EAR-E102）；耳温计（EAR-E103）Shenzhen AOJ Medical Technology Co., Ltd.K243000可重复使用温度探头（T1306, T2306, T3306, T4306）；一次性温度探头（T5106, T6106）Shenzhen Medke Technology Co., Ltd.K250878优威尔® 红外耳温枪（YHT100）；优威尔® 红外耳温枪（YHT107）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082红外体温计Guangzhou Daxin Health Technology Co., Ltd.

官方来源

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