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

    BERNOULLI ENTERPRISE SOFTWARE

    K Number: K130208 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    9
    Review Days
    326

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    Basic Information

    Device Name
    BERNOULLI ENTERPRISE SOFTWARE
    K Number
    K130208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardiopulmonary Corp.
    Date Received
    January 28, 2013
    Decision Date
    December 20, 2013
    Product Code
    MHX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Cardiopulmonary Corp.

    K Number Device Name
    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
    K990429 MODIFICATION OF VENTURI VENTILATOR
    K982174 VENTURI VENTILATOR
    K943412 VENTURI VENTILATOR