FDA 510(k)

宙斯系统

K号: K222389 · 2023-02-15

决定日期2023-02-15

产品代码DQK

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

ZEUS System 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 2023-02-15 under 510(k) number K222389. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZEUS System?

ZEUS System is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is iRhythm Technologies, Inc.. The 510(k) number is K222389.

When did ZEUS System receive FDA 510(k) clearance?

ZEUS System received FDA 510(k) clearance on 2023-02-15, under 510(k) number K222389.

Who is the listed applicant for ZEUS System?

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 ZEUS System?

The FDA product code for ZEUS System is DQK.

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）K243650Zio®监护仪（DFG0001）K240177Zio AT®设备（A100A1001）K240029Zio AT®设备（A100A1001）K213409宙斯系统（Zio手表）K202359Zio 监测仪

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官方来源

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