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FDA 510(k)

虚拟C DRF数字成像系统

K号: K211191 · 2021-06-24

决定日期2021-06-24
产品代码OWB
咨询委员会RA
决定实质等同

器械摘要

Virtual C DRF Digital Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Portavision Medical, LLC. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K211191. 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 Virtual C DRF Digital Imaging System?

Virtual C DRF Digital Imaging System is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Portavision Medical, LLC. The 510(k) number is K211191.

When did Virtual C DRF Digital Imaging System receive FDA 510(k) clearance?

Virtual C DRF Digital Imaging System received FDA 510(k) clearance on 2021-06-24, under 510(k) number K211191.

Who is the listed applicant for Virtual C DRF Digital Imaging System?

The FDA 510(k) record lists Portavision Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virtual C DRF Digital Imaging System?

The FDA product code for Virtual C DRF Digital Imaging System is OWB.

相关临床试验

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列明Portavision Medical, LLC为申报人的其他记录

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相关器械(代码:OWB)

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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