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

    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER

    K Number: K021470 · Decision Nov 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    33
    Review Days
    190

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    Basic Information

    Device Name
    SEER LIGHT COMPACT DIGITAL HOLTER RECORDER
    K Number
    K021470
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Electric Medical Systems Information Techn
    Date Received
    May 8, 2002
    Decision Date
    November 14, 2002
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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