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

    EAST-FREEMAN VENTILATOR MARK 2

    K Number: K812958 · Decision Jan 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    78

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    Basic Information

    Device Name
    EAST-FREEMAN VENTILATOR MARK 2
    K Number
    K812958
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cairco , Ltd.
    Date Received
    October 21, 1981
    Decision Date
    January 7, 1982
    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 Cairco , Ltd.

    K Number Device Name
    K812961 SHEFFIELD INFANT VENTILATOR MARK 4
    K812957 EAST AUTOCLAVE HUMIDIFIER
    K812959 SPIROX A
    K812956 SPIROX H
    K812955 EAST WATER UNIT MARK 3
    K812953 RADCLIFFE VENTILATOR MARK 5
    K812960 EAST VENTILARM PRESSURE MONITOR ALARM S.
    K810640 POLARISED LIGHT GRONIOMETER