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FDA 510(k)

Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System

K号: K152223 · 2016-04-29

申请人Oxyheal Medical Systems, Inc.
决定日期2016-04-29
产品代码CBF
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决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Oxyheal Medical Systems, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K163109OxyHeal 4000多部位高压氧舱系列

相关器械（代码：CBF）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240569FESL FINK腔室；FEDL FINK腔室；FETL FINK腔室Fink Engineering Pty, Ltd.K220290Revitalair 430+Us Hyperbaric NetworkK171899Revitalair 430FOxavita SrlK163109OxyHeal 4000多部位高压氧舱系列Oxyheal Medical Systems, Inc.

官方来源

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