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

    ATRIA 3100, ATRIA 6100

    K Number: K060167 · Decision Apr 19, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    ATRIA 3100, ATRIA 6100
    K Number
    K060167
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiac Science Corporation
    Date Received
    January 23, 2006
    Decision Date
    April 19, 2006
    Product Code
    DPS
    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
    DPS Electrocardiograph

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