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FDA 510(k)

OXLIFE EXCELL OXYGEN CONCENTRATORS

K-Number: K971964 · 1997-08-15

ApplicantOxlife, Inc.
Decision Date1997-08-15
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXLIFE EXCELL OXYGEN CONCENTRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Oxlife, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K971964. 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 EXCELL OXYGEN CONCENTRATORS?

OXLIFE EXCELL OXYGEN CONCENTRATORS is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Oxlife, Inc.. The 510(k) number is K971964.

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

OXLIFE EXCELL OXYGEN CONCENTRATORS received FDA 510(k) clearance on 1997-08-15, under 510(k) number K971964.

Who is the listed applicant for OXLIFE EXCELL OXYGEN CONCENTRATORS?

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

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

The FDA product code for OXLIFE EXCELL 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, 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.

K955549OXLIFE OXYGEN CONCENTRATORSK933081OXLIFE OXYGEN CONCENTRATOR

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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