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FDA 510(k)

INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM

K-Number: K003472 · 2001-06-04

ApplicantSequal Technologies, Inc.
Decision Date2001-06-04
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM is the device name listed in this FDA 510(k) record. The listed applicant is Sequal Technologies, Inc.. It received FDA 510(k) clearance on 2001-06-04 under 510(k) number K003472. 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 INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM?

INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM is a medical device that received FDA 510(k) clearance on 2001-06-04. The listed applicant is Sequal Technologies, Inc.. The 510(k) number is K003472.

When did INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM receive FDA 510(k) clearance?

INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM received FDA 510(k) clearance on 2001-06-04, under 510(k) number K003472.

Who is the listed applicant for INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM?

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

What is the FDA product code for INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM?

The FDA product code for INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM is CAW.

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Other records listing Sequal Technologies, 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.

K083163OMNI 2 OXYGEN SYSTEMK042262INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10K013931OMNI OXYGEN SYSTEM, MODEL 1000

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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