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FDA 510(k)

MRI PPG 患者电缆

K号: K203653 · 2021-03-02

决定日期2021-03-02
产品代码LNH
咨询委员会RA
决定实质等同

器械摘要

MRI PPG Patient Cable 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 2021-03-02 under 510(k) number K203653. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MRI PPG Patient Cable?

MRI PPG Patient Cable is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K203653.

When did MRI PPG Patient Cable receive FDA 510(k) clearance?

MRI PPG Patient Cable received FDA 510(k) clearance on 2021-03-02, under 510(k) number K203653.

Who is the listed applicant for MRI PPG Patient Cable?

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 MRI PPG Patient Cable?

The FDA product code for MRI PPG Patient Cable is LNH.

相关临床试验

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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。

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相关器械(代码:LNH)

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

在 FDA 数据库中查看 →

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。

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