FDA 510(k)

Digiscan FDX

K号: K200218 · 2020-07-13

决定日期2020-07-13

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

Digiscan FDX is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Medical Systems Limited. It received FDA 510(k) clearance on 2020-07-13 under 510(k) number K200218. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Digiscan FDX?

Digiscan FDX is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Allengers Medical Systems Limited. The 510(k) number is K200218.

When did Digiscan FDX receive FDA 510(k) clearance?

Digiscan FDX received FDA 510(k) clearance on 2020-07-13, under 510(k) number K200218.

Who is the listed applicant for Digiscan FDX?

The FDA 510(k) record lists Allengers Medical Systems Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digiscan FDX?

The FDA product code for Digiscan FDX is OWB.

列明Allengers Medical Systems Limited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。

K2532963D数字C-ARM K243734无线/有线X射线平板探测器 K223009无线/有线X射线平板探测器 K223060DigiX FDX K220311Cardiovascular Angiography System K192541DigiX FDX

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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。