BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ES-100 POWER SYSTEM, ES-100 SERIES

    K Number: K925360 · Decision Sep 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    40
    Applicant Total
    8
    Review Days
    320

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    Basic Information

    Device Name
    ES-100 POWER SYSTEM, ES-100 SERIES
    K Number
    K925360
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elekta Instruments, Inc.
    Date Received
    October 22, 1992
    Decision Date
    September 7, 1993
    Product Code
    GEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEY Motor, Surgical Instrument, Ac-Powered

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