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FDA 510(k)

PREMIER O2 OXYGEN CONCENTRATOR

K-Number: K844223 · 1984-12-24

ApplicantEverest & Jennings, Inc.
Decision Date1984-12-24
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PREMIER O2 OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Everest & Jennings, Inc.. It received FDA 510(k) clearance on 1984-12-24 under 510(k) number K844223. 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 PREMIER O2 OXYGEN CONCENTRATOR?

PREMIER O2 OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1984-12-24. The listed applicant is Everest & Jennings, Inc.. The 510(k) number is K844223.

When did PREMIER O2 OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

PREMIER O2 OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1984-12-24, under 510(k) number K844223.

Who is the listed applicant for PREMIER O2 OXYGEN CONCENTRATOR?

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

What is the FDA product code for PREMIER O2 OXYGEN CONCENTRATOR?

The FDA product code for PREMIER O2 OXYGEN CONCENTRATOR is CAW.

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Other records listing Everest & Jennings, 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.

K925865KID POWERK940303RECORDK940304NITROK930413PREMIER CLASSICK930412PREMIER 2 WHEELCHAIRK930411UNIVERSAL WHEELCHAIR

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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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