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

    NEWPORT E360 VENTILATOR

    K Number: K053502 · Decision Jan 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    22
    Review Days
    25

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    Basic Information

    Device Name
    NEWPORT E360 VENTILATOR
    K Number
    K053502
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    December 16, 2005
    Decision Date
    January 10, 2006
    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 Newport Medical Instruments, Inc.

    K Number Device Name
    K121891 NEWPORT AURA VENTILATOR
    K111146 NEWPORT HT70 VENTILATOR
    K101803 NEWPORT E360 VENTILATOR
    K090888 NEWPORT HT70 FAMILY OF VENTILATORS
    K082724 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
    K061094 NEWPORT E500 WAVE VENTILATOR
    K041082 NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
    K030780 NEWPORT E500 WAVE VENTILATOR
    K992133 NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
    K972833 E100M VENTILATOR (E100M)
    Search all 22 clearances from Newport Medical Instruments, Inc. →