FDA 510(k)

Zio®监护仪（DFG0001）

K号: K243650 · 2025-08-15

决定日期2025-08-15

产品代码DSH

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

Zio® monitor (DFG0001) is the device name listed in this FDA 510(k) record. The listed applicant is iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K243650. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Zio® monitor (DFG0001)?

Zio® monitor (DFG0001) is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K243650.

When did Zio® monitor (DFG0001) receive FDA 510(k) clearance?

Zio® monitor (DFG0001) received FDA 510(k) clearance on 2025-08-15, under 510(k) number K243650.

Who is the listed applicant for Zio® monitor (DFG0001)?

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

What is the FDA product code for Zio® monitor (DFG0001)?

The FDA product code for Zio® monitor (DFG0001) is DSH.

列明iRhythm Technologies, 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。

K252859宙斯平台（FG0501US）K240177Zio AT®设备（A100A1001）K240029Zio AT®设备（A100A1001）K222389宙斯系统 K213409宙斯系统（Zio手表）K202359Zio 监测仪

查看所有 11 个设备 →

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。