FDA 510(k)

Quantum 诊断模块, Quantum 诊断模块 - 无气体

K号: K173591 · 2018-03-28

决定日期2018-03-28

产品代码DRY

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

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K173591. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K173591.

When did Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas receive FDA 510(k) clearance?

Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas received FDA 510(k) clearance on 2018-03-28, under 510(k) number K173591.

Who is the listed applicant for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

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

What is the FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas?

The FDA product code for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas is DRY.

列明Spectrum Medical , 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。

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官方来源

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