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FDA 510(k)

MINI O2

K-Number: K812513 · 1981-09-21

ApplicantMountain Medical Equipment, Inc.
Decision Date1981-09-21
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI O2 is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Medical Equipment, Inc.. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K812513. 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 MINI O2?

MINI O2 is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Mountain Medical Equipment, Inc.. The 510(k) number is K812513.

When did MINI O2 receive FDA 510(k) clearance?

MINI O2 received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812513.

Who is the listed applicant for MINI O2?

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

What is the FDA product code for MINI O2?

The FDA product code for MINI O2 is CAW.

Other records listing Mountain Medical Equipment, Inc. as applicant

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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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