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FDA 510(k)

CATALOG 6400 OXYGEN CONCENTRATOR

K-Number: K833938 · 1983-12-08

ApplicantHudson Oxygen Therapy Sales Co.
Decision Date1983-12-08
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATALOG 6400 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hudson Oxygen Therapy Sales Co.. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833938. 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 CATALOG 6400 OXYGEN CONCENTRATOR?

CATALOG 6400 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Hudson Oxygen Therapy Sales Co.. The 510(k) number is K833938.

When did CATALOG 6400 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

CATALOG 6400 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833938.

Who is the listed applicant for CATALOG 6400 OXYGEN CONCENTRATOR?

The FDA 510(k) record lists Hudson Oxygen Therapy Sales Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATALOG 6400 OXYGEN CONCENTRATOR?

The FDA product code for CATALOG 6400 OXYGEN CONCENTRATOR is CAW.

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Other records listing Hudson Oxygen Therapy Sales Co. 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.

K902062PEEP VALVEK900783MDI ADAPTORK900470IN-THE NEBULIZERK895589MANUAL RESUSCITATORK896136INFANT C.P.A.P. MONITORK895231CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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