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FDA 510(k)

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES

K-Number: K100920 · 2010-11-29

ApplicantSequal Technologies Co., Ltd.
Decision Date2010-11-29
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Sequal Technologies Co., Ltd.. It received FDA 510(k) clearance on 2010-11-29 under 510(k) number K100920. 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 MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES is a medical device that received FDA 510(k) clearance on 2010-11-29. The listed applicant is Sequal Technologies Co., Ltd.. The 510(k) number is K100920.

When did MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES receive FDA 510(k) clearance?

MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES received FDA 510(k) clearance on 2010-11-29, under 510(k) number K100920.

Who is the listed applicant for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

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

What is the FDA product code for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES?

The FDA product code for MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES is CAW.

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Other records listing Sequal Technologies Co., Ltd. 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.

K091541MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES

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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