FDA 510(k)

NOxBOXi 氮氧化物輸送系統

K 號：K220898 · 2022-04-27

決定日期2022-04-27

產品代碼MRN

諮詢委員會AN

決定相當於

器材摘要

NOxBOXi Nitric Oxide Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Linde Gas & Equipment, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220898. The device is classified under product code MRN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NOxBOXi Nitric Oxide Delivery System?

NOxBOXi Nitric Oxide Delivery System is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Linde Gas & Equipment, Inc.. The 510(k) number is K220898.

When did NOxBOXi Nitric Oxide Delivery System receive FDA 510(k) clearance?

NOxBOXi Nitric Oxide Delivery System received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220898.

Who is the listed applicant for NOxBOXi Nitric Oxide Delivery System?

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

What is the FDA product code for NOxBOXi Nitric Oxide Delivery System?

The FDA product code for NOxBOXi Nitric Oxide Delivery System is MRN.

其他以 Linde Gas & Equipment, 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。

K233251NOxBOXi 氮氧化物輸送系統 K231823NOxBOXi 氮氧化物輸送系統

相關器械（代碼：MRN）

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。

K242374ULSPIRA TS™ 一氧化氮治療系統Airgas Therapeutics, LLC K242578EVOLVE 氧化氮輸送系統Mallinckrodt Manufacturing, LLC K240410EVOLVE 氧化氮輸送系統Malinckrodt Manufacturing, LLC K233251NOxBOXi 氮氧化物輸送系統Linde Gas & Equipment, Inc.K222930進化一氧化氮輸送系統Mallinckrodt Manufacturing, LLC K231823NOxBOXi 氮氧化物輸送系統Linde Gas & Equipment, Inc.

官方來源

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