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

    MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

    K Number: K073625 · Decision Jan 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM
    K Number
    K073625
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Healthcare Systems Information Technologies
    Date Received
    December 26, 2007
    Decision Date
    January 25, 2008
    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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