FDA 510(k)

Caremed 患者电缆和导线

K号: K153188 · 2016-10-24

申请人Shenzhen Caremed Medical Technology Co., Ltd.

决定日期2016-10-24

产品代码DSA

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

Caremed patient cable and leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K153188. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Caremed patient cable and leadwires?

Caremed patient cable and leadwires is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K153188.

When did Caremed patient cable and leadwires receive FDA 510(k) clearance?

Caremed patient cable and leadwires received FDA 510(k) clearance on 2016-10-24, under 510(k) number K153188.

Who is the listed applicant for Caremed patient cable and leadwires?

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

What is the FDA product code for Caremed patient cable and leadwires?

The FDA product code for Caremed patient cable and leadwires is DSA.

列明Shenzhen Caremed Medical 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。

K191279一次性SpO2传感器 K182751可重复使用温度探头 K182755一次性温度探头 K182433可重复使用血压袖带，一次性血压袖带 K153184Caremed 可重复使用和一次性 SPO2 传感器

相关器械（代码：DSA）

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。

官方来源

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