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

    MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)

    K Number: K920295 · Decision Aug 18, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    48
    Review Days
    209

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    Basic Information

    Device Name
    MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED)
    K Number
    K920295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oxford Medilog, Inc.
    Date Received
    January 22, 1992
    Decision Date
    August 18, 1992
    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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