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

    ANS SYSTEM

    K Number: K101016 · Decision Jan 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    570
    Applicant Total
    3
    Review Days
    291

    Basic Information

    Device Name
    ANS SYSTEM
    K Number
    K101016
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    CAIRD TECHNOLOGY
    Date Received
    April 12, 2010
    Decision Date
    January 28, 2011
    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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