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FDA 510(k)

HF 718BD X射线系统

K号: K160857 · 2017-02-24

决定日期2017-02-24
产品代码KPR
咨询委员会RA
决定实质等同

器械摘要

HF 718BD X-Ray System is the device name listed in this FDA 510(k) record. The listed applicant is Arquilla, Inc. Dba X-Cel X-Ray Corporation. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K160857. 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 HF 718BD X-Ray System?

HF 718BD X-Ray System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Arquilla, Inc. Dba X-Cel X-Ray Corporation. The 510(k) number is K160857.

When did HF 718BD X-Ray System receive FDA 510(k) clearance?

HF 718BD X-Ray System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K160857.

Who is the listed applicant for HF 718BD X-Ray System?

The FDA 510(k) record lists Arquilla, Inc. Dba X-Cel X-Ray Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF 718BD X-Ray System?

The FDA product code for HF 718BD X-Ray System is KPR.

相关临床试验

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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