FDA 510(k)

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System

K号: K200022 · 2020-04-03

决定日期2020-04-03

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Livermoretech, Inc.. It received FDA 510(k) clearance on 2020-04-03 under 510(k) number K200022. 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 FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is Livermoretech, Inc.. The 510(k) number is K200022.

When did FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System receive FDA 510(k) clearance?

FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System received FDA 510(k) clearance on 2020-04-03, under 510(k) number K200022.

Who is the listed applicant for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

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

What is the FDA product code for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System?

The FDA product code for FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System is OWB.

列明Livermoretech, 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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