FDA 510(k)

氧康4000多處置式高壓氧氣療法室系列

K 號：K163109 · 2017-03-22

決定日期2017-03-22

產品代碼CBF

諮詢委員會AN

決定相當於

器材摘要

OxyHeal 4000 Multiplace Hyperbaric Chamber Family 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 2017-03-22 under 510(k) number K163109. 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 OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

OxyHeal 4000 Multiplace Hyperbaric Chamber Family is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is Oxyheal Medical Systems, Inc.. The 510(k) number is K163109.

When did OxyHeal 4000 Multiplace Hyperbaric Chamber Family receive FDA 510(k) clearance?

OxyHeal 4000 Multiplace Hyperbaric Chamber Family received FDA 510(k) clearance on 2017-03-22, under 510(k) number K163109.

Who is the listed applicant for OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

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 OxyHeal 4000 Multiplace Hyperbaric Chamber Family?

The FDA product code for OxyHeal 4000 Multiplace Hyperbaric Chamber Family is CBF.

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。

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

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 Network K171899Revitalair 430FOxavita Srl 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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