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

    SORBA MODEL CIC-1000 W/NEW ELECTRODES

    K Number: K901926 · Decision Jun 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    4
    Review Days
    43

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    Basic Information

    Device Name
    SORBA MODEL CIC-1000 W/NEW ELECTRODES
    K Number
    K901926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Sorba Medical Systems, Inc.
    Date Received
    April 30, 1990
    Decision Date
    June 12, 1990
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

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    Other Clearances by Sorba Medical Systems, Inc.

    K Number Device Name
    K014299 SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
    K950389 SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR
    K895017 SORBA MODEL CIC-1000, COMP. IMPEDANCE CARDIOGRAPH