FDA 510(k)

心脏触发监测器

K号: K202138 · 2021-05-14

决定日期2021-05-14

产品代码DRT

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

Cardiac Trigger Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K202138. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardiac Trigger Monitor?

Cardiac Trigger Monitor is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K202138.

When did Cardiac Trigger Monitor receive FDA 510(k) clearance?

Cardiac Trigger Monitor received FDA 510(k) clearance on 2021-05-14, under 510(k) number K202138.

Who is the listed applicant for Cardiac Trigger Monitor?

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

What is the FDA product code for Cardiac Trigger Monitor?

The FDA product code for Cardiac Trigger Monitor is DRT.

列明Ivy Biomedical Systems, 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。

K240087RT Carbon ECG Leads K203653MRI PPG 患者电缆 K192852MRI ECG 患者电缆 K171778MR 无线门控系统，型号 WGS-100 K170828心脏触发监测器 K151781心脏触发监测器，心脏与监管同步监测器

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。