FDA 510(k)

Ablamap® 系统

K号: K230008 · 2023-06-08

决定日期2023-06-08

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

Ablamap® System is the device name listed in this FDA 510(k) record. The listed applicant is Ablacon, Inc.. It received FDA 510(k) clearance on 2023-06-08 under 510(k) number K230008. 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 Ablamap® System?

Ablamap® System is a medical device that received FDA 510(k) clearance on 2023-06-08. The listed applicant is Ablacon, Inc.. The 510(k) number is K230008.

When did Ablamap® System receive FDA 510(k) clearance?

Ablamap® System received FDA 510(k) clearance on 2023-06-08, under 510(k) number K230008.

Who is the listed applicant for Ablamap® System?

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

What is the FDA product code for Ablamap® System?

The FDA product code for Ablamap® System is DQK.

列明Ablacon, 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。

K223666Ablacath™ 映射导管 K203084Ablamap 软件

官方来源

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