BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ARM-A-VIAL LV SODIUM CHLORIDE INHALAT

    K Number: K841989 · Decision Jul 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    79

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    Basic Information

    Device Name
    ARM-A-VIAL LV SODIUM CHLORIDE INHALAT
    K Number
    K841989
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Armour Pharmaceutical Co.
    Date Received
    May 9, 1984
    Decision Date
    July 27, 1984
    Product Code
    CCQ
    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
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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    Other Clearances by Armour Pharmaceutical Co.

    K Number Device Name
    K842209 ARM-A-FLOW INTRAVENOUS FLOW REGULATOR
    K844005 ARM-A-VIAL LV HEATER-BREATHING SYS
    K841991 ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS
    K841988 ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT
    K841987 ARM-A-VIAL LV STERIAL WATER FOR INHALA
    K841990 ARM-A-CARE NEBULIZER-NEBULIZER