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

    MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST

    K Number: K904832 · Decision Apr 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    230
    Review Days
    181

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    Basic Information

    Device Name
    MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
    K Number
    K904832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hewlett-Packard Co.
    Date Received
    October 23, 1990
    Decision Date
    April 22, 1991
    Product Code
    DXK
    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
    DXK Echocardiograph

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