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

    NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR

    K Number: K940739 · Decision Mar 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    13
    Applicant Total
    22
    Review Days
    383

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    Basic Information

    Device Name
    NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR
    K Number
    K940739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Newport Medical Instruments, Inc.
    Date Received
    February 17, 1994
    Decision Date
    March 7, 1995
    Product Code
    MOD
    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
    MOD Accessory To Continuous Ventilator (Respirator)

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    Other Clearances by Newport Medical Instruments, Inc.

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    K082724 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
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    K053502 NEWPORT E360 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
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