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FDA 510(k)

OXYTRON OXYGEN GENERATOR

K-Number: K813018 · 1981-11-06

ApplicantElmore Technology Corp.
Decision Date1981-11-06
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYTRON OXYGEN GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Elmore Technology Corp.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K813018. 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 OXYTRON OXYGEN GENERATOR?

OXYTRON OXYGEN GENERATOR is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Elmore Technology Corp.. The 510(k) number is K813018.

When did OXYTRON OXYGEN GENERATOR receive FDA 510(k) clearance?

OXYTRON OXYGEN GENERATOR received FDA 510(k) clearance on 1981-11-06, under 510(k) number K813018.

Who is the listed applicant for OXYTRON OXYGEN GENERATOR?

The FDA 510(k) record lists Elmore Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYTRON OXYGEN GENERATOR?

The FDA product code for OXYTRON OXYGEN GENERATOR 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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