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FDA 510(k)

COMPANION 492 OXYGEN CONCENTRATOR

K-Number: K843243 · 1984-08-22

ApplicantPuritan Bennett Corp.
Decision Date1984-08-22
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COMPANION 492 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Puritan Bennett Corp.. It received FDA 510(k) clearance on 1984-08-22 under 510(k) number K843243. 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 COMPANION 492 OXYGEN CONCENTRATOR?

COMPANION 492 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1984-08-22. The listed applicant is Puritan Bennett Corp.. The 510(k) number is K843243.

When did COMPANION 492 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

COMPANION 492 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1984-08-22, under 510(k) number K843243.

Who is the listed applicant for COMPANION 492 OXYGEN CONCENTRATOR?

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

What is the FDA product code for COMPANION 492 OXYGEN CONCENTRATOR?

The FDA product code for COMPANION 492 OXYGEN CONCENTRATOR is CAW.

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Other records listing Puritan Bennett Corp. 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.

K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONK023225PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWAREK022103PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEMK001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONK002001BREEZE SLEEPGEAR WITH DREAMSEAL

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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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