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FDA 510(k)

OMNI 3 OXYGEN SYSTEM

K-Number: K120785 · 2012-10-25

ApplicantCaire, Inc.
Decision Date2012-10-25
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMNI 3 OXYGEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Caire, Inc.. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K120785. 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 OMNI 3 OXYGEN SYSTEM?

OMNI 3 OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is Caire, Inc.. The 510(k) number is K120785.

When did OMNI 3 OXYGEN SYSTEM receive FDA 510(k) clearance?

OMNI 3 OXYGEN SYSTEM received FDA 510(k) clearance on 2012-10-25, under 510(k) number K120785.

Who is the listed applicant for OMNI 3 OXYGEN SYSTEM?

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

What is the FDA product code for OMNI 3 OXYGEN SYSTEM?

The FDA product code for OMNI 3 OXYGEN SYSTEM is CAW.

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Other records listing Caire, 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.

K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)K121167CAIRE COMPANION 5 OXYGEN CONCENTRATORK080023MODIFICATION TO: SPIRITK050153SPIRIT, MODEL HASK013251SPIRIT 300K952268MODEL DELTA, OM OXYGEN CONCENTRATOR

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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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