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FDA 510(k)

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

K 號：K152223 · 2016-04-29

申請人Oxyheal Medical Systems, Inc.
決定日期2016-04-29
產品代碼CBF
諮詢委員會AN
決定相當於

器材摘要

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is the device name listed in this FDA 510(k) record. The listed applicant is Oxyheal Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152223. 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 Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Oxyheal Medical Systems, Inc.. The 510(k) number is K152223.

When did Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System receive FDA 510(k) clearance?

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152223.

Who is the listed applicant for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

The FDA 510(k) record lists Oxyheal Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System?

The FDA product code for Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System 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

其他以 Oxyheal Medical Systems, 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。

K163109氧康4000多處置式高壓氧氣療法室系列

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.K220290Revitalair 430+Us Hyperbaric NetworkK171899Revitalair 430FOxavita SrlK163109氧康4000多處置式高壓氧氣療法室系列Oxyheal Medical Systems, Inc.

官方來源

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