BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    ECONOM

    K Number: K925754 · Decision Oct 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    11
    Applicant Total
    30
    Review Days
    329

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    Basic Information

    Device Name
    ECONOM
    K Number
    K925754
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    November 13, 1992
    Decision Date
    October 8, 1993
    Product Code
    EPY
    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
    EPY Speculum, Ent

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    K950914 RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
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