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510(k) Data Aggregation

    K Number
    K024023
    Device Name
    ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
    Manufacturer
    ESSEX MEDICAL SYSTEMS PLUS
    Date Cleared
    2003-10-01

    (300 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ESSEX MEDICAL SYSTEMS PLUS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver are used to deliver a prescribed flow of gas to the patient while conserving gas, by sensing the patient inhalation cycle and supplying gas only during that phase of breathing.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing authorization letter for the "Essex High Pressure (HP) OCD and Essex Escort Pneumatic Conserver" (K024023) and does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

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