FDA 510(k)

RT Carbon ECG Leads

K号: K240087 · 2024-09-13

决定日期2024-09-13

产品代码DSA

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

RT Carbon ECG Leads is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240087. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RT Carbon ECG Leads?

RT Carbon ECG Leads is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K240087.

When did RT Carbon ECG Leads receive FDA 510(k) clearance?

RT Carbon ECG Leads received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240087.

Who is the listed applicant for RT Carbon ECG Leads?

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

What is the FDA product code for RT Carbon ECG Leads?

The FDA product code for RT Carbon ECG Leads is DSA.

列明Ivy Biomedical Systems, 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。

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相关器械（代码：DSA）

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。

官方来源

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