FDA 510(k)

AcQMap® 高分辨率成像和制图系统

K号: K230606 · 2023-05-02

决定日期2023-05-02

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

AcQMap® High Resolution Imaging and Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230606. 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 AcQMap® High Resolution Imaging and Mapping System?

AcQMap® High Resolution Imaging and Mapping System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K230606.

When did AcQMap® High Resolution Imaging and Mapping System receive FDA 510(k) clearance?

AcQMap® High Resolution Imaging and Mapping System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230606.

Who is the listed applicant for AcQMap® High Resolution Imaging and Mapping System?

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

What is the FDA product code for AcQMap® High Resolution Imaging and Mapping System?

The FDA product code for AcQMap® High Resolution Imaging and Mapping System is DQK.

列明Acutus 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。

K233691FlexCath 跨隔膜解决方案 K231091AcQMap 高分辨率成像和映射系统 K222209AcQMap 高分辨率成像和映射系统 K220784AcQMap 高分辨率成像和映射系统 K210766AcQMap 3D 成像和映射导管，型号 900009 K221044AcQGuide® VUE 可控导丝

查看所有 24 个设备 →

官方来源

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