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FDA 510(k)

OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS

K-Number: K080082 · 2008-04-16

ApplicantOxlife, LLC
Decision Date2008-04-16
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Oxlife, LLC. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080082. 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 OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS?

OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Oxlife, LLC. The 510(k) number is K080082.

When did OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS receive FDA 510(k) clearance?

OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080082.

Who is the listed applicant for OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS?

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

What is the FDA product code for OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS?

The FDA product code for OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS is CAW.

Related Clinical Trials

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.

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Other records listing Oxlife, LLC 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.

K060922OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5

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.

K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)Oxytek Medical Technology Co., Ltd.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, LLC

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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