FDA 510(k)

脑自主调节指数（CAI）算法

K号: K240596 · 2024-10-16

决定日期2024-10-16

产品代码MUD

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

Cerebral Autoregulation Index (CAI) Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K240596. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cerebral Autoregulation Index (CAI) Algorithm?

Cerebral Autoregulation Index (CAI) Algorithm is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Edwards Lifesciences. The 510(k) number is K240596.

When did Cerebral Autoregulation Index (CAI) Algorithm receive FDA 510(k) clearance?

Cerebral Autoregulation Index (CAI) Algorithm received FDA 510(k) clearance on 2024-10-16, under 510(k) number K240596.

Who is the listed applicant for Cerebral Autoregulation Index (CAI) Algorithm?

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

What is the FDA product code for Cerebral Autoregulation Index (CAI) Algorithm?

The FDA product code for Cerebral Autoregulation Index (CAI) Algorithm is MUD.

列明Edwards Lifesciences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。

K254232ECLIPTIS 左心耳附壁排除系统 (ECS135)；ECLIPTIS 左心耳附壁排除系统 (ECS140)；ECLIPTIS 左心耳附壁排除系统 (ECS145)；ECLIPTIS 左心耳附壁排除系统 (ECS150)K260105Fogarty 弹簧夹，无手柄夹具和夹具插入物 K254279Edwards eSheath+ 引导器套装 K252533HemoSphere Alta高级监测平台（ALTAALL1; ALTACR1; ALTASR1）K253034HemoSphere Stream模块 K252364Edwards eSheath Optima 引导器套装

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。