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FDA 510(k)

THE GENERIC OXYGEN CONCENTRATOR

K-Number: K844852 · 1984-12-27

ApplicantProto-Med, Inc.
Decision Date1984-12-27
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE GENERIC OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Proto-Med, Inc.. It received FDA 510(k) clearance on 1984-12-27 under 510(k) number K844852. 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 THE GENERIC OXYGEN CONCENTRATOR?

THE GENERIC OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1984-12-27. The listed applicant is Proto-Med, Inc.. The 510(k) number is K844852.

When did THE GENERIC OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

THE GENERIC OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1984-12-27, under 510(k) number K844852.

Who is the listed applicant for THE GENERIC OXYGEN CONCENTRATOR?

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

What is the FDA product code for THE GENERIC OXYGEN CONCENTRATOR?

The FDA product code for THE GENERIC 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 Proto-Med, 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.

K822301ROYAL 1 OXYGEN CONCENTRATORK820115EMMETT IUD THREAD RETREIVERK811761THE EMMETT IUD THREAD RETRIEVER

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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