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FDA 510(k)

GCE Zen-O Portable Oxygen Concentrator

K-Number: K162433 · 2017-05-24

ApplicantOxus, Inc.
Decision Date2017-05-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Oxus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211056Oxus Sieve Beds

Related Devices (Code: CAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)BMC Medical Co., Ltd.K252399Portable Oxygen ConcentratorHonsun (Nantong) Co., Ltd.K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.K252407OxyGo Portable Oxygen Concentrator (1400-7000)Mv Life, LLCK253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLCK251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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