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FDA 510(k)

OXYGENATOR

K-Number: K002632 · 2001-10-25

ApplicantAdjunctive Therapeutics, Inc.
Decision Date2001-10-25
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OXYGENATOR is the device name listed in this FDA 510(k) record. The listed applicant is Adjunctive Therapeutics, Inc.. It received FDA 510(k) clearance on 2001-10-25 under 510(k) number K002632. 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 OXYGENATOR?

OXYGENATOR is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Adjunctive Therapeutics, Inc.. The 510(k) number is K002632.

When did OXYGENATOR receive FDA 510(k) clearance?

OXYGENATOR received FDA 510(k) clearance on 2001-10-25, under 510(k) number K002632.

Who is the listed applicant for OXYGENATOR?

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

What is the FDA product code for OXYGENATOR?

The FDA product code for OXYGENATOR 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, 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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