FDA 510(k)

FLUSION-9001，顯影C臂移動X光系統

K 號：K200022 · 2020-04-03

決定日期2020-04-03

產品代碼OWB

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Livermoretech, Inc. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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