FDA 510(k)

心电图一次性导联线

K号: K170536 · 2017-04-24

决定日期2017-04-24

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

ECG Disposable Lead Wire is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K170536. 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 ECG Disposable Lead Wire?

ECG Disposable Lead Wire is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K170536.

When did ECG Disposable Lead Wire receive FDA 510(k) clearance?

ECG Disposable Lead Wire received FDA 510(k) clearance on 2017-04-24, under 510(k) number K170536.

Who is the listed applicant for ECG Disposable Lead Wire?

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

What is the FDA product code for ECG Disposable Lead Wire?

The FDA product code for ECG Disposable Lead Wire is DSA.

列明APK 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。

K250425紫外线光疗设备 K172981可重复使用SpO2传感器，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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