FDA 510(k)

加热冷却系统3T

K号: K191402 · 2020-02-25

决定日期2020-02-25

产品代码DWC

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

Heater-Cooler System 3T is the device name listed in this FDA 510(k) record. The listed applicant is Livanova Deutschland, GmbH. It received FDA 510(k) clearance on 2020-02-25 under 510(k) number K191402. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Heater-Cooler System 3T?

Heater-Cooler System 3T is a medical device that received FDA 510(k) clearance on 2020-02-25. The listed applicant is Livanova Deutschland, GmbH. The 510(k) number is K191402.

When did Heater-Cooler System 3T receive FDA 510(k) clearance?

Heater-Cooler System 3T received FDA 510(k) clearance on 2020-02-25, under 510(k) number K191402.

Who is the listed applicant for Heater-Cooler System 3T?

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

What is the FDA product code for Heater-Cooler System 3T?

The FDA product code for Heater-Cooler System 3T is DWC.

列明Livanova Deutschland, GmbH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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