FDA 510(k)

氧氣-W系統

K 號：K200141 · 2020-04-27

決定日期2020-04-27

產品代碼MWI

諮詢委員會履歷

決定相當於

器材摘要

Oxi-W System is the device name listed in this FDA 510(k) record. The listed applicant is Ld Technology, LLC. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200141. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Oxi-W System?

Oxi-W System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Ld Technology, LLC. The 510(k) number is K200141.

When did Oxi-W System receive FDA 510(k) clearance?

Oxi-W System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200141.

Who is the listed applicant for Oxi-W System?

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

What is the FDA product code for Oxi-W System?

The FDA product code for Oxi-W System is MWI.

其他以 Ld Technology, LLC 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。

K200287BP-BT 選擇機 K173696TBL-ABI 系統 K160956LD-Oxi系統

相關器械（代碼：MWI）

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。

K260438生命徵象監測器（CLEO2）Infinium Medical, Inc.K253417馬斯美Root監控系統Masimo Corporation K253196Midmark 800 電子生命徵象儀器（1-300-0100，1-300-0200，1-300-0300，1-300-0400）Midmark Corporation K253436c-med0 阿爾法Cosinuss GmbH K250135WAVE醫療平台（2.0.000）Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo、Hemo Lite、PCM、GO、Hybrid)Fysicon BV

官方來源

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