FDA 510(k)

MoMe ARC® 无线便携式心电图监测和检测系统 (32000)

K号: K250356 · 2025-07-29

决定日期2025-07-29

产品代码DSI

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

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is the device name listed in this FDA 510(k) record. The listed applicant is Infobionic, Inc.. It received FDA 510(k) clearance on 2025-07-29 under 510(k) number K250356. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is a medical device that received FDA 510(k) clearance on 2025-07-29. The listed applicant is Infobionic, Inc.. The 510(k) number is K250356.

When did MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) receive FDA 510(k) clearance?

MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) received FDA 510(k) clearance on 2025-07-29, under 510(k) number K250356.

Who is the listed applicant for MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

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

What is the FDA product code for MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)?

The FDA product code for MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) is DSI.

列明Infobionic, 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。

K230265MoMe® ARC 无线便携式心电图监测和检测系统 K160064MoMe Kardia 无线便携式心电图监测和检测系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。