FDA 510(k)

EZER，可攜式X光系統

K 號：K193535 · 2020-05-07

決定日期2020-05-07

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

EZER, Portable 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 2020-05-07 under 510(k) number K193535. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZER, Portable X-ray System?

EZER, Portable X-ray System is a medical device that received FDA 510(k) clearance on 2020-05-07. The listed applicant is Livermoretech, Inc.. The 510(k) number is K193535.

When did EZER, Portable X-ray System receive FDA 510(k) clearance?

EZER, Portable X-ray System received FDA 510(k) clearance on 2020-05-07, under 510(k) number K193535.

Who is the listed applicant for EZER, Portable 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 EZER, Portable X-ray System?

The FDA product code for EZER, Portable X-ray System is IZL.

其他以 Livermoretech, Inc. 為申請人之記錄

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。

K244049歐羅巴（備選名稱：AiRTouch）可攜帶式X光系統 K200022FLUSION-9001，顯影C臂移動X光系統 K193644E-COM DR-2000 DR 医療設備規範文本 E-COM DR-2000 DR 医療設備，FDA 認證，510(k) 認可，PMA 認證，NCT 研究編號，PMID 文獻編號，識別碼及網址。K190935EZER，可攜式X光系統 K180663LaVid FMTS 診斷 X 光系統

相關器械（代碼：IZL）

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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