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

    ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

    K Number: K131045 · Decision May 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    2
    Review Days
    44

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    Basic Information

    Device Name
    ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
    K Number
    K131045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cardiac Designs, LLC
    Date Received
    April 15, 2013
    Decision Date
    May 29, 2013
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Cardiac Designs, LLC

    K Number Device Name
    K122184 ECG CHECK