FDA 510(k)

eMurmur ID

K号: K181988 · 2019-04-17

决定日期2019-04-17

产品代码DQD

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

eMurmur ID is the device name listed in this FDA 510(k) record. The listed applicant is Csd Labs GmbH. It received FDA 510(k) clearance on 2019-04-17 under 510(k) number K181988. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the eMurmur ID?

eMurmur ID is a medical device that received FDA 510(k) clearance on 2019-04-17. The listed applicant is Csd Labs GmbH. The 510(k) number is K181988.

When did eMurmur ID receive FDA 510(k) clearance?

eMurmur ID received FDA 510(k) clearance on 2019-04-17, under 510(k) number K181988.

Who is the listed applicant for eMurmur ID?

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

What is the FDA product code for eMurmur ID?

The FDA product code for eMurmur ID is DQD.

列明Csd Labs 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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官方来源

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