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FDA 510(k)

BIO CARE OXYGEN CONCENTRATOR

K-Number: K810272 · 1981-02-25

ApplicantThe Biomed Group
Decision Date1981-02-25
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIO CARE OXYGEN CONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is The Biomed Group. It received FDA 510(k) clearance on 1981-02-25 under 510(k) number K810272. 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 BIO CARE OXYGEN CONCENTRATOR?

BIO CARE OXYGEN CONCENTRATOR is a medical device that received FDA 510(k) clearance on 1981-02-25. The listed applicant is The Biomed Group. The 510(k) number is K810272.

When did BIO CARE OXYGEN CONCENTRATOR receive FDA 510(k) clearance?

BIO CARE OXYGEN CONCENTRATOR received FDA 510(k) clearance on 1981-02-25, under 510(k) number K810272.

Who is the listed applicant for BIO CARE OXYGEN CONCENTRATOR?

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

What is the FDA product code for BIO CARE OXYGEN CONCENTRATOR?

The FDA product code for BIO CARE OXYGEN CONCENTRATOR is CAW.

Related Clinical Trials

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.

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Other records listing The Biomed Group 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.

K813311COMPRESSOR, AIR, PORTABLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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