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FDA 510(k)

SunTech CT40 Spot-check Vital Signs Device

K号: K160439 · 2016-07-06

申请人Suntech Medical
决定日期2016-07-06
产品代码DXN
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

SunTech CT40 Spot-check Vital Signs Device is the device name listed in this FDA 510(k) record. The listed applicant is Suntech Medical. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K160439. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SunTech CT40 Spot-check Vital Signs Device?

SunTech CT40 Spot-check Vital Signs Device is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Suntech Medical. The 510(k) number is K160439.

When did SunTech CT40 Spot-check Vital Signs Device receive FDA 510(k) clearance?

SunTech CT40 Spot-check Vital Signs Device received FDA 510(k) clearance on 2016-07-06, under 510(k) number K160439.

Who is the listed applicant for SunTech CT40 Spot-check Vital Signs Device?

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

What is the FDA product code for SunTech CT40 Spot-check Vital Signs Device?

The FDA product code for SunTech CT40 Spot-check Vital Signs Device is DXN.

相关临床试验

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：DXN）

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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