FDA 510(k)

AcQMap 3D 成像和映射导管，型号 900009

K号: K210766 · 2022-06-21

决定日期2022-06-21

产品代码MTD

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 3D Imaging and Mapping Catheter, Model 900009 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 2022-06-21 under 510(k) number K210766. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AcQMap 3D Imaging and Mapping Catheter, Model 900009?

AcQMap 3D Imaging and Mapping Catheter, Model 900009 is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210766.

When did AcQMap 3D Imaging and Mapping Catheter, Model 900009 receive FDA 510(k) clearance?

AcQMap 3D Imaging and Mapping Catheter, Model 900009 received FDA 510(k) clearance on 2022-06-21, under 510(k) number K210766.

Who is the listed applicant for AcQMap 3D Imaging and Mapping Catheter, Model 900009?

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 3D Imaging and Mapping Catheter, Model 900009?

The FDA product code for AcQMap 3D Imaging and Mapping Catheter, Model 900009 is MTD.

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。

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官方来源

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