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

    KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM

    K Number: K875334 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    57
    Review Days
    85

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    Basic Information

    Device Name
    KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
    K Number
    K875334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Kontron Instruments, Inc.
    Date Received
    December 30, 1987
    Decision Date
    March 24, 1988
    Product Code
    HGL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGL Transducer, Ultrasonic, Obstetric

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