FDA 510(k)

Cardio P1

K号: K231150 · 2023-11-09

决定日期2023-11-09

产品代码DPS

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Cardio P1 is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Co., Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231150. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardio P1?

Cardio P1 is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Bionet Co., Ltd.. The 510(k) number is K231150.

When did Cardio P1 receive FDA 510(k) clearance?

Cardio P1 received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231150.

Who is the listed applicant for Cardio P1?

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

What is the FDA product code for Cardio P1?

The FDA product code for Cardio P1 is DPS.

列明Bionet Co., Ltd.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。

K231160Cardio Q50, Cardio Q70 K220535Cardio10 K220169SonoMe无线探头型超声扫描仪（型号：5C，5CB，H5C，10L，14L，10LB，H10L，H5C10L）和SonoFinder无线探头型超声扫描仪（型号：SF14L25）

官方来源

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