FDA 510(k)

知情生命核心应用（IVC应用）

K号: K241633 · 2024-11-18

决定日期2024-11-18

产品代码QME

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

Informed Vital Core Application (IVC App) is the device name listed in this FDA 510(k) record. The listed applicant is Mindset Medical, Inc.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K241633. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Informed Vital Core Application (IVC App)?

Informed Vital Core Application (IVC App) is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Mindset Medical, Inc.. The 510(k) number is K241633.

When did Informed Vital Core Application (IVC App) receive FDA 510(k) clearance?

Informed Vital Core Application (IVC App) received FDA 510(k) clearance on 2024-11-18, under 510(k) number K241633.

Who is the listed applicant for Informed Vital Core Application (IVC App)?

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

What is the FDA product code for Informed Vital Core Application (IVC App)?

The FDA product code for Informed Vital Core Application (IVC App) is QME.

列明Mindset Medical, 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。

K250078知情生命核心应用（IVC应用）（v2.0.0.2.0.0）

官方来源

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