BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    MODIFICATION OF VENTURI VENTILATOR

    K Number: K990429 · Decision Feb 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    MODIFICATION OF VENTURI VENTILATOR
    K Number
    K990429
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Cardiopulmonary Corp.
    Date Received
    February 11, 1999
    Decision Date
    February 24, 1999
    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 Cardiopulmonary Corp.

    K Number Device Name
    K130208 BERNOULLI ENTERPRISE SOFTWARE
    K091461 BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
    K061932 BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
    K051283 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
    K020018 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
    K011861 BERNOULLI VENTILATOR MANAGEMENT SYSTEM
    K982174 VENTURI VENTILATOR
    K943412 VENTURI VENTILATOR