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FDA 510(k)

OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8

K-Number: K880044 · 1988-03-28

ApplicantOxygen Enrichment Company, Ltd.
Decision Date1988-03-28
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 is the device name listed in this FDA 510(k) record. The listed applicant is Oxygen Enrichment Company, Ltd.. It received FDA 510(k) clearance on 1988-03-28 under 510(k) number K880044. 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 OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8?

OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 is a medical device that received FDA 510(k) clearance on 1988-03-28. The listed applicant is Oxygen Enrichment Company, Ltd.. The 510(k) number is K880044.

When did OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 receive FDA 510(k) clearance?

OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 received FDA 510(k) clearance on 1988-03-28, under 510(k) number K880044.

Who is the listed applicant for OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8?

The FDA 510(k) record lists Oxygen Enrichment Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8?

The FDA product code for OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 is CAW.

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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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