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FDA 510(k)

SYSTEM ONE OXYGEN CONCENTRATOR

K-Number: K821393 · 1982-08-10

ApplicantMarathon
Decision Date1982-08-10
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM ONE OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Marathon. It received FDA 510(k) clearance on 1982-08-10 under 510(k) number K821393. 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 SYSTEM ONE OXYGEN CONCENTRATOR?

SYSTEM ONE OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1982-08-10. The listed applicant is Marathon. The 510(k) number is K821393.

When did SYSTEM ONE OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

SYSTEM ONE OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1982-08-10, under 510(k) number K821393.

Who is the listed applicant for SYSTEM ONE OXYGEN CONCENTRATOR?

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

What is the FDA product code for SYSTEM ONE OXYGEN CONCENTRATOR?

The FDA product code for SYSTEM ONE OXYGEN CONCENTRATOR 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 Marathon 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.

K821392MODEL TPC-1 OXYGEN ANALYZERK821520MODEL 379 FLOW/DIVIDER

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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