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

    RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT

    K Number: K964338 · Decision Jan 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    70

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    Basic Information

    Device Name
    RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
    K Number
    K964338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1780
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    October 31, 1996
    Decision Date
    January 9, 1997
    Product Code
    HKM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKM Retinoscope, Battery-Powered

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    Other Clearances by Rudolf Riester GmbH & Co. KG

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    K972379 PRECISA N
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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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    K945541 SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
    K945425 MCINTOSH, MILLER, FOREGGER BABY
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