BEUDAMED
    Product Code: ECX FDA class 1 21 CFR 868.2700

    Cylinder, Compressed Gas, And Valve

    Anesthesiology

    The Compressed Gas Cylinder and Valve is a container and control assembly used to store and dispense medical or dental gases such as oxygen, nitrous oxide, or nitrogen under pressure, used in anesthesia, sedation, and other clinical applications. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is ECX and the applicable regulation is 21 CFR 868.2700, under the Anesthesiology medical specialty.

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    510(k)s
    13
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    12
    Years Active
    40

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    Basic Information

    Product Code
    ECX
    Device Class
    FDA class 1
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 13 510(k) clearances via K numbers.

    K Number Device Name
    K161179 Intelli-Ox
    K161472 Walk-O2-Bout
    K153518 Medipure Oxygen-LC System
    K143060 Intelli-Ox
    K142149 OXYTOTE INFINITY SERIES VIPR SYSTEMS
    K132778 GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
    K131386 EZ-OX PLUS GENERATION II
    K101792 LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
    K063354 LINDE INTEGRATED VALVE (LIV)
    K062300 OX-SOX, MODEL C, D, E,
    K053117 EZ-OX PLUS
    K033897 MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
    K771246 ALARM SYS FOR NITROUS OXIDE SYS.

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.