FDA 510(k)

HeartBeam AIMIGo与12-L ECG合成软件系统

K号: K250258 · 2025-12-08

决定日期2025-12-08

产品代码DXH

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

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is the device name listed in this FDA 510(k) record. The listed applicant is Heartbeam, Inc.. It received FDA 510(k) clearance on 2025-12-08 under 510(k) number K250258. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

HeartBeam AIMIGo with 12-L ECG Synthesis Software System is a medical device that received FDA 510(k) clearance on 2025-12-08. The listed applicant is Heartbeam, Inc.. The 510(k) number is K250258.

When did HeartBeam AIMIGo with 12-L ECG Synthesis Software System receive FDA 510(k) clearance?

HeartBeam AIMIGo with 12-L ECG Synthesis Software System received FDA 510(k) clearance on 2025-12-08, under 510(k) number K250258.

Who is the listed applicant for HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

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

What is the FDA product code for HeartBeam AIMIGo with 12-L ECG Synthesis Software System?

The FDA product code for HeartBeam AIMIGo with 12-L ECG Synthesis Software System is DXH. This falls under the Hematology category.

列明Heartbeam, 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。

K231424HeartBeam AIMIGo™系统

官方来源

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