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FDA 510(k)

Revitalair 430+

K 號：K220290 · 2023-05-04

申請人Us Hyperbaric Network
決定日期2023-05-04
產品代碼CBF
諮詢委員會AN
決定相當於

器材摘要

Revitalair 430+ is the device name listed in this FDA 510(k) record. The listed applicant is Us Hyperbaric Network. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K220290. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Revitalair 430+?

Revitalair 430+ is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Us Hyperbaric Network. The 510(k) number is K220290.

When did Revitalair 430+ receive FDA 510(k) clearance?

Revitalair 430+ received FDA 510(k) clearance on 2023-05-04, under 510(k) number K220290.

Who is the listed applicant for Revitalair 430+?

The FDA 510(k) record lists Us Hyperbaric Network as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revitalair 430+?

The FDA product code for Revitalair 430+ is CBF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：CBF）

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。

K240569FESL FINK 腔室；FEDL FINK 腔室；FETL FINK 腔室Fink Engineering Pty, Ltd.K171899Revitalair 430FOxavita SrlK163109氧康4000多處置式高壓氧氣療法室系列Oxyheal Medical Systems, Inc.K152223長方形多處置高壓氧氣療法室系統產品系列，配備觸控式控制系統Oxyheal Medical Systems, Inc.

官方來源

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