BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PNEUTON VENTILATOR

    K Number: K024344 · Decision Jun 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    4
    Review Days
    158

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    Basic Information

    Device Name
    PNEUTON VENTILATOR
    K Number
    K024344
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Airon Corporation
    Date Received
    December 27, 2002
    Decision Date
    June 3, 2003
    Product Code
    CBK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by Airon Corporation

    K Number Device Name
    K121379 PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
    K080692 MACS CPAP SYSTEM
    K043085 MODIFICATION TO: PNEUTON VENTILATOR