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

    SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

    K Number: K011729 · Decision Aug 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    87

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    Basic Information

    Device Name
    SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
    K Number
    K011729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dni Nevada, Inc.
    Date Received
    June 4, 2001
    Decision Date
    August 30, 2001
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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