FDA 510(k)

患者电缆和导线，一次性ECG导线

K号: K182327 · 2019-01-30

决定日期2019-01-30

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 Cables and Leadwires , Disposable ECG Leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K182327. 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 Cables and Leadwires , Disposable ECG Leadwires?

Patient Cables and Leadwires , Disposable ECG Leadwires is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Orantech, Inc.. The 510(k) number is K182327.

When did Patient Cables and Leadwires , Disposable ECG Leadwires receive FDA 510(k) clearance?

Patient Cables and Leadwires , Disposable ECG Leadwires received FDA 510(k) clearance on 2019-01-30, under 510(k) number K182327.

Who is the listed applicant for Patient Cables and Leadwires , Disposable ECG Leadwires?

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

What is the FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires?

The FDA product code for Patient Cables and Leadwires , Disposable ECG Leadwires is DSA.

列明Orantech, Inc.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。

K173194温度探头 K181270一次性SpO2传感器，可重复使用SpO2传感器 K173197可重复使用NIBP袖带 K171828ETCO2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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