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

    12 LEAD GLOVE

    K Number: K100315 · Decision Apr 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    1
    Review Days
    78

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    Basic Information

    Device Name
    12 LEAD GLOVE
    K Number
    K100315
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I Needmd, Inc.
    Date Received
    February 4, 2010
    Decision Date
    April 23, 2010
    Product Code
    DRX
    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
    DRX Electrode, Electrocardiograph

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