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510(k) Data Aggregation

    K Number
    K946127
    Device Name
    OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
    Manufacturer
    OHMEDA MEDICAL
    Date Cleared
    1996-10-08

    (663 days)

    Product Code
    BSZ
    Regulation Number
    868.5160
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K863207
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.

    Device Description

    The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube.

    AI/ML Overview

    This document is a 510(k) summary for the Ohmeda Excel Draw-Over Military Vaporizer System, seeking to establish substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on regulatory classification, substantial equivalence arguments, and design modifications of the device.

    Therefore, I cannot provide the requested information.

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