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FDA 510(k)

PORTABLE OXYGEN GENERATOR

K-Number: K915381 · 1992-03-11

ApplicantAequitron Medical, Inc.
Decision Date1992-03-11
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTABLE OXYGEN GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1992-03-11 under 510(k) number K915381. 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 PORTABLE OXYGEN GENERATOR?

PORTABLE OXYGEN GENERATOR is a medical device that received FDA 510(k) clearance on 1992-03-11. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K915381.

When did PORTABLE OXYGEN GENERATOR receive FDA 510(k) clearance?

PORTABLE OXYGEN GENERATOR received FDA 510(k) clearance on 1992-03-11, under 510(k) number K915381.

Who is the listed applicant for PORTABLE OXYGEN GENERATOR?

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

What is the FDA product code for PORTABLE OXYGEN GENERATOR?

The FDA product code for PORTABLE OXYGEN GENERATOR is CAW.

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Other records listing Aequitron Medical, 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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