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FDA 510(k)

OXYGEN CONCENTRATOR, MODEL BX-5000

K-Number: K854374 · 1986-01-03

ApplicantHealthdyne, Inc.
Decision Date1986-01-03
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN CONCENTRATOR, MODEL BX-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K854374. 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 OXYGEN CONCENTRATOR, MODEL BX-5000?

OXYGEN CONCENTRATOR, MODEL BX-5000 is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is Healthdyne, Inc.. The 510(k) number is K854374.

When did OXYGEN CONCENTRATOR, MODEL BX-5000 receive FDA 510(k) clearance?

OXYGEN CONCENTRATOR, MODEL BX-5000 received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854374.

Who is the listed applicant for OXYGEN CONCENTRATOR, MODEL BX-5000?

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 OXYGEN CONCENTRATOR, MODEL BX-5000?

The FDA product code for OXYGEN CONCENTRATOR, MODEL BX-5000 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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