FDA 510(k)

低射血分数AI-ECG算法

K号: K232699 · 2023-09-28

决定日期2023-09-28

产品代码QYE

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

Low Ejection Fraction AI-ECG Algorithm is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2023-09-28 under 510(k) number K232699. The device is classified under product code QYE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Low Ejection Fraction AI-ECG Algorithm?

Low Ejection Fraction AI-ECG Algorithm is a medical device that received FDA 510(k) clearance on 2023-09-28. The listed applicant is Anumana, Inc.. The 510(k) number is K232699.

When did Low Ejection Fraction AI-ECG Algorithm receive FDA 510(k) clearance?

Low Ejection Fraction AI-ECG Algorithm received FDA 510(k) clearance on 2023-09-28, under 510(k) number K232699.

Who is the listed applicant for Low Ejection Fraction AI-ECG Algorithm?

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

What is the FDA product code for Low Ejection Fraction AI-ECG Algorithm?

The FDA product code for Low Ejection Fraction AI-ECG Algorithm is QYE.

列明Anumana, 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。

K260300WatchMate 软件 K253801ECG-AI 心脏淀粉样变性（CA）12导联算法（1040）K252360ECG-AI 肺动脉高压（PH）12导联算法（1020）K250652ECG-AI 低射血分数（LEF）12导联算法（1010）K233160NeuTrace EP映射系统v.2.1

官方来源

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