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FDA 510(k)

TANSCU O2

K-Number: K090681 · 2009-08-12

ApplicantElectrochemical Oxygen Concepts, Inc.
Decision Date2009-08-12
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TANSCU O2 is the device name listed in this FDA 510(k) record. The listed applicant is Electrochemical Oxygen Concepts, Inc.. It received FDA 510(k) clearance on 2009-08-12 under 510(k) number K090681. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANSCU O2?

TANSCU O2 is a medical device that received FDA 510(k) clearance on 2009-08-12. The listed applicant is Electrochemical Oxygen Concepts, Inc.. The 510(k) number is K090681.

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

TANSCU O2 received FDA 510(k) clearance on 2009-08-12, under 510(k) number K090681.

Who is the listed applicant for TANSCU O2?

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

What is the FDA product code for TANSCU O2?

The FDA product code for TANSCU O2 is KPJ.

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Related Devices (Code: KPJ)

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.

K250188Wound Treatment System (VHT-200)Vaporox, Inc.K212121VHT-200 Wound Treatment SystemVaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba OgenixK112634NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODPInotec Amd , Ltd.K120764EPIFLO(R)Neogenix, LLCK080966HYPER-BOX TOPICAL WOUND OXYGEN SYSTEMAoti , Ltd.

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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