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

    SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E

    K Number: K022132 · Decision Sep 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    781
    Review Days
    80

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    Basic Information

    Device Name
    SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
    K Number
    K022132
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    July 1, 2002
    Decision Date
    September 19, 2002
    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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