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FDA 510(k)

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM

K-Number: K080966 · 2008-08-06

ApplicantAoti , Ltd.
Decision Date2008-08-06
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aoti , Ltd.. It received FDA 510(k) clearance on 2008-08-06 under 510(k) number K080966. 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 HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM?

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-06. The listed applicant is Aoti , Ltd.. The 510(k) number is K080966.

When did HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM receive FDA 510(k) clearance?

HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM received FDA 510(k) clearance on 2008-08-06, under 510(k) number K080966.

Who is the listed applicant for HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM?

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

What is the FDA product code for HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM?

The FDA product code for HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM is KPJ.

Related Clinical Trials

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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, LLCK090681TANSCU O2Electrochemical Oxygen Concepts, Inc.

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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