FDA 510(k)

FEops HEARTguide Simulation Application

K号: K250635 · 2025-11-25

决定日期2025-11-25

产品代码QQI

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

FEops HEARTguide Simulation Application is the device name listed in this FDA 510(k) record. The listed applicant is Feops NV. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K250635. The device is classified under product code QQI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FEops HEARTguide Simulation Application?

FEops HEARTguide Simulation Application is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Feops NV. The 510(k) number is K250635.

When did FEops HEARTguide Simulation Application receive FDA 510(k) clearance?

FEops HEARTguide Simulation Application received FDA 510(k) clearance on 2025-11-25, under 510(k) number K250635.

Who is the listed applicant for FEops HEARTguide Simulation Application?

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

What is the FDA product code for FEops HEARTguide Simulation Application?

The FDA product code for FEops HEARTguide Simulation Application is QQI.

列明Feops NV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。

K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACA K214066FEops HEARTguide

官方来源

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