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

    SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM

    K Number: K050731 · Decision May 19, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    136
    Review Days
    59

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    Basic Information

    Device Name
    SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM
    K Number
    K050731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    March 21, 2005
    Decision Date
    May 19, 2005
    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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