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

    MAC-LAB/CARDIOLAB EP/COMBOLAB

    K Number: K021366 · Decision Jul 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    33
    Review Days
    64

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    Basic Information

    Device Name
    MAC-LAB/CARDIOLAB EP/COMBOLAB
    K Number
    K021366
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    General Electric Medical Systems Information Techn
    Date Received
    April 30, 2002
    Decision Date
    July 3, 2002
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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