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

    ACCESSORY TO GENESIS III (GCFM)

    K Number: K913209 · Decision May 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    39
    Review Days
    301

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    Basic Information

    Device Name
    ACCESSORY TO GENESIS III (GCFM)
    K Number
    K913209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosound, Inc.
    Date Received
    July 19, 1991
    Decision Date
    May 15, 1992
    Product Code
    DXK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXK Echocardiograph

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    Other Clearances by Biosound, Inc.

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    K953716 INTRACAVITY TRANSDUCERS
    K953530 DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A
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