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FDA 510(k)

Televere 足部X射线系统 HF

K号: K180765 · 2018-04-20

决定日期2018-04-20
产品代码KPR
咨询委员会RA
决定实质等同

器械摘要

Televere Podiatry X-Ray System HF is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180765. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Televere Podiatry X-Ray System HF?

Televere Podiatry X-Ray System HF is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Televere Systems, Inc.. The 510(k) number is K180765.

When did Televere Podiatry X-Ray System HF receive FDA 510(k) clearance?

Televere Podiatry X-Ray System HF received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180765.

Who is the listed applicant for Televere Podiatry X-Ray System HF?

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

What is the FDA product code for Televere Podiatry X-Ray System HF?

The FDA product code for Televere Podiatry X-Ray System HF is KPR.

相关临床试验

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列明Televere 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。

相关器械(代码:KPR)

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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