FDA 510(k)

GCE Zen-O Portable Oxygen Concentrator

K号: K162433 · 2017-05-24

决定日期2017-05-24

产品代码CAW

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决定实质等同

器械摘要

GCE Zen-O Portable Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Oxus, Inc.. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K162433. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GCE Zen-O Portable Oxygen Concentrator?

GCE Zen-O Portable Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is Oxus, Inc.. The 510(k) number is K162433.

When did GCE Zen-O Portable Oxygen Concentrator receive FDA 510(k) clearance?

GCE Zen-O Portable Oxygen Concentrator received FDA 510(k) clearance on 2017-05-24, under 510(k) number K162433.

Who is the listed applicant for GCE Zen-O Portable Oxygen Concentrator?

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

What is the FDA product code for GCE Zen-O Portable Oxygen Concentrator?

The FDA product code for GCE Zen-O Portable Oxygen Concentrator is CAW.

列明Oxus, 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。

K211056Oxus筛床

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