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

    EIDOSMED, MODEL EDG4.0

    K Number: K091992 · Decision Dec 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    160

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    Basic Information

    Device Name
    EIDOSMED, MODEL EDG4.0
    K Number
    K091992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eidosmed, LLC
    Date Received
    July 2, 2009
    Decision Date
    December 9, 2009
    Product Code
    OOL
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OOL Electronic Depth Gauge