BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    PRECISA

    K Number: K925294 · Decision Feb 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    30
    Review Days
    490

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    Basic Information

    Device Name
    PRECISA
    K Number
    K925294
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    October 21, 1992
    Decision Date
    February 23, 1994
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

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    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
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