FDA 510(k)

ECG-AI 肺动脉高压（PH）12导联算法（1020）

K号: K252360 · 2026-03-28

决定日期2026-03-28

产品代码SAT

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

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is the device name listed in this FDA 510(k) record. The listed applicant is Anumana, Inc.. It received FDA 510(k) clearance on 2026-03-28 under 510(k) number K252360. The device is classified under product code SAT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is a medical device that received FDA 510(k) clearance on 2026-03-28. The listed applicant is Anumana, Inc.. The 510(k) number is K252360.

When did ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) receive FDA 510(k) clearance?

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) received FDA 510(k) clearance on 2026-03-28, under 510(k) number K252360.

Who is the listed applicant for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

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 ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)?

The FDA product code for ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) is SAT.

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）K250652ECG-AI 低射血分数（LEF）12导联算法（1010）K233160NeuTrace EP映射系统v.2.1 K232699低射血分数AI-ECG算法

官方来源

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