FDA 510(k)

Medke 氧饱和度手指传感器

K号: K152390 · 2016-08-18

决定日期2016-08-18

产品代码DQA

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

Medke Oximetry Finger Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Medke Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K152390. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medke Oximetry Finger Sensor?

Medke Oximetry Finger Sensor is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Shenzhen Medke Technology Co., Ltd.. The 510(k) number is K152390.

When did Medke Oximetry Finger Sensor receive FDA 510(k) clearance?

Medke Oximetry Finger Sensor received FDA 510(k) clearance on 2016-08-18, under 510(k) number K152390.

Who is the listed applicant for Medke Oximetry Finger Sensor?

The FDA 510(k) record lists Shenzhen Medke Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medke Oximetry Finger Sensor?

The FDA product code for Medke Oximetry Finger Sensor is DQA.

列明Shenzhen Medke Technology Co., 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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相关器械（代码：DQA）

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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