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FDA 510(k)

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR

K-Number: K851435 · 1985-07-29

ApplicantInvacare Corp.
Decision Date1985-07-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corp.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K851435. 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 PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR?

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Invacare Corp.. The 510(k) number is K851435.

When did PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1985-07-29, under 510(k) number K851435.

Who is the listed applicant for PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR?

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

What is the FDA product code for PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR?

The FDA product code for PRIME AIRE O, MODEL PA02 2 O OXYGEN CONCENTRATOR is CAW.

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Other records listing Invacare 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.

K071928THE INVACARE FLYER, MODEL IPC 100K070321TWILIGHT FULL FACE MASKK062402EASYSTAND EVOLVK061874INVACARE'S TWILIGHT II NASAL MASKSK033819INVACARE 3G TARSYSK031176INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000

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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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