FDA 510(k)

AccurECG Analysis System

K号: K223013 · 2023-06-23

决定日期2023-06-23

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

AccurECG Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Accurkardia, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K223013. 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 AccurECG Analysis System?

AccurECG Analysis System is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Accurkardia, Inc.. The 510(k) number is K223013.

When did AccurECG Analysis System receive FDA 510(k) clearance?

AccurECG Analysis System received FDA 510(k) clearance on 2023-06-23, under 510(k) number K223013.

Who is the listed applicant for AccurECG Analysis System?

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

What is the FDA product code for AccurECG Analysis System?

The FDA product code for AccurECG Analysis System is DPS.

列明Accurkardia, 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。

K252361AccurECG Analysis System (v2.0)

官方来源

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