BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

    K Number: K071348 · Decision Sep 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    21
    Review Days
    116

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    Basic Information

    Device Name
    EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
    K Number
    K071348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mennen Medical , Ltd.
    Date Received
    May 14, 2007
    Decision Date
    September 7, 2007
    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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