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

    BIG BEN SQUARE, BIG BEN ROUND

    K Number: K972301 · Decision Sep 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    30
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BIG BEN SQUARE, BIG BEN ROUND
    K Number
    K972301
    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 19, 1997
    Decision Date
    September 17, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXQ), ordered by most recent decision date.

    YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1681S-C51N)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Arm Type Blood Pressure Monitor Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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
    K972377 RI-MEGA
    K972378 SANAPHON N
    K972379 PRECISA N
    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 →