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

    MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024

    K Number: K012263 · Decision Oct 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    12
    Review Days
    84

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    Basic Information

    Device Name
    MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
    K Number
    K012263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Custom Ent., Inc.
    Date Received
    July 18, 2001
    Decision Date
    October 10, 2001
    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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