BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

    K Number: K002544 · Decision Sep 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    403
    Applicant Total
    2
    Review Days
    27

    Basic Information

    Device Name
    MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM
    K Number
    K002544
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OXFORD INSTRUMENTS
    Date Received
    August 17, 2000
    Decision Date
    September 13, 2000
    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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