FDA 510(k)

患者监护电缆（SpO2 扩展电缆）

K号: K192404 · 2020-06-22

决定日期2020-06-22

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

Patient Monitoring Cable (SpO2 Extension Cable) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K192404. 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 Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Shenzhen Coreray Technology, Ltd.. The 510(k) number is K192404.

When did Patient Monitoring Cable (SpO2 Extension Cable) receive FDA 510(k) clearance?

Patient Monitoring Cable (SpO2 Extension Cable) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K192404.

Who is the listed applicant for Patient Monitoring Cable (SpO2 Extension Cable)?

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

What is the FDA product code for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA product code for Patient Monitoring Cable (SpO2 Extension Cable) is DSA.

列明Shenzhen Coreray Technology, 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。

K173368可重复使用和一次性SpO2传感器 K172797ECG 电缆/导联线

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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