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

    ECLIPSE 4 ELECTROCARDIOGRAPH

    K Number: K943959 · Decision May 17, 1995
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    6
    Review Days
    275

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    Basic Information

    Device Name
    ECLIPSE 4 ELECTROCARDIOGRAPH
    K Number
    K943959
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Burdick, Inc.
    Date Received
    August 15, 1994
    Decision Date
    May 17, 1995
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

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