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FDA 510(k)

KMI OXY-BAN

K-Number: K883848 · 1989-03-02

ApplicantKnight Medical, Inc.
Decision Date1989-03-02
Product CodeKPJ
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

KMI OXY-BAN is the device name listed in this FDA 510(k) record. The listed applicant is Knight Medical, Inc.. It received FDA 510(k) clearance on 1989-03-02 under 510(k) number K883848. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KMI OXY-BAN?

KMI OXY-BAN is a medical device that received FDA 510(k) clearance on 1989-03-02. The listed applicant is Knight Medical, Inc.. The 510(k) number is K883848.

When did KMI OXY-BAN receive FDA 510(k) clearance?

KMI OXY-BAN received FDA 510(k) clearance on 1989-03-02, under 510(k) number K883848.

Who is the listed applicant for KMI OXY-BAN?

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

What is the FDA product code for KMI OXY-BAN?

The FDA product code for KMI OXY-BAN is KPJ.

Other records listing Knight Medical, 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.

K921127PANDA NEEDLE CATHETER JEJUNOSTOMY KITK903086TUBE GASTROSTOMYK883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMK862489ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE

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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