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

    UNI I

    K Number: K925759 · Decision Jul 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    55
    Applicant Total
    30
    Review Days
    255

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    Basic Information

    Device Name
    UNI I
    K Number
    K925759
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4770
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    November 13, 1992
    Decision Date
    July 26, 1993
    Product Code
    ERA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERA Otoscope

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    K972301 BIG BEN SQUARE, BIG BEN ROUND
    K964338 RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
    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
    K950913 PERFECT, ENT SET, PRAKTIKANT, DE LUXE
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