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

    RI-MEGA

    K Number: K972377 · Decision Sep 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    30
    Review Days
    90

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    Basic Information

    Device Name
    RI-MEGA
    K Number
    K972377
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rudolf Riester GmbH & Co. KG
    Date Received
    June 26, 1997
    Decision Date
    September 24, 1997
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

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    Other Clearances by Rudolf Riester GmbH & Co. KG

    K Number Device Name
    K002955 EMPIRE N BLOOD PRESSURE MANOMETERS
    K002954 RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
    K972378 SANAPHON N
    K972379 PRECISA N
    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
    K945541 SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE
    K945425 MCINTOSH, MILLER, FOREGGER BABY
    Search all 30 clearances from Rudolf Riester GmbH & Co. KG →