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

    PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH

    K Number: K002459 · Decision Nov 8, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    30
    Review Days
    90

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    Basic Information

    Device Name
    PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
    K Number
    K002459
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Agilent Technologies, Inc.
    Date Received
    August 10, 2000
    Decision Date
    November 8, 2000
    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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