FDA 510(k)

Stethee Pro 1, Stethee Pro 软件系统

K号: K193631 · 2020-10-09

决定日期2020-10-09

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

Stethee Pro 1, Stethee Pro Software System is the device name listed in this FDA 510(k) record. The listed applicant is M3Dicine Pty , Ltd.. It received FDA 510(k) clearance on 2020-10-09 under 510(k) number K193631. 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 Stethee Pro 1, Stethee Pro Software System?

Stethee Pro 1, Stethee Pro Software System is a medical device that received FDA 510(k) clearance on 2020-10-09. The listed applicant is M3Dicine Pty , Ltd.. The 510(k) number is K193631.

When did Stethee Pro 1, Stethee Pro Software System receive FDA 510(k) clearance?

Stethee Pro 1, Stethee Pro Software System received FDA 510(k) clearance on 2020-10-09, under 510(k) number K193631.

Who is the listed applicant for Stethee Pro 1, Stethee Pro Software System?

The FDA 510(k) record lists M3Dicine Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stethee Pro 1, Stethee Pro Software System?

The FDA product code for Stethee Pro 1, Stethee Pro Software System is DQD.

列明M3Dicine Pty , Ltd.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。

K172296Stethee Pro

官方来源

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