FDA 510(k)

Sapphire II PRO

K号: K173680 · 2018-03-01

决定日期2018-03-01

产品代码LOX

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

Sapphire II PRO is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-03-01 under 510(k) number K173680. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sapphire II PRO?

Sapphire II PRO is a medical device that received FDA 510(k) clearance on 2018-03-01. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K173680.

When did Sapphire II PRO receive FDA 510(k) clearance?

Sapphire II PRO received FDA 510(k) clearance on 2018-03-01, under 510(k) number K173680.

Who is the listed applicant for Sapphire II PRO?

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

What is the FDA product code for Sapphire II PRO?

The FDA product code for Sapphire II PRO is LOX.

列明Orbusneich Medical Trading, 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。

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