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FDA 510(k)

MODEL BX-3000 OXYGEN CONCENTRATOR

K-Number: K822871 · 1982-10-22

ApplicantHealthdyne, Inc.
Decision Date1982-10-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL BX-3000 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1982-10-22 under 510(k) number K822871. 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 MODEL BX-3000 OXYGEN CONCENTRATOR?

MODEL BX-3000 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1982-10-22. The listed applicant is Healthdyne, Inc.. The 510(k) number is K822871.

When did MODEL BX-3000 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

MODEL BX-3000 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1982-10-22, under 510(k) number K822871.

Who is the listed applicant for MODEL BX-3000 OXYGEN CONCENTRATOR?

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

What is the FDA product code for MODEL BX-3000 OXYGEN CONCENTRATOR?

The FDA product code for MODEL BX-3000 OXYGEN CONCENTRATOR is CAW.

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Other records listing Healthdyne, 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.

K950331PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)K922106ALICEK942357H-500 ALLIANCE OXYGEN CONCENTRATORK934502FLOW SPIROMETERK924146OH-500 OXYGEN CONCENTRATORK922623NEBULIZER SYSTEM

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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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