BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    BLOOD PRESSURE MONITOR

    K Number: K112690 · Decision Feb 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    21
    Review Days
    162

    Basic Information

    Device Name
    BLOOD PRESSURE MONITOR
    K Number
    K112690
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NIHON SEIMITSU SOKKI CO., LTD.
    Date Received
    September 15, 2011
    Decision Date
    February 24, 2012
    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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    Other Clearances by NIHON SEIMITSU SOKKI CO., LTD.

    K Number Device Name
    K112620 DISITAL BLOOD PRESSURE MONITOR
    K112691 BLOOD PRESSURE MONITOR
    K093102 AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
    K080177 WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
    K071596 POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
    K071384 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
    K061086 DM-3000 DIGITAL BLOOD PRESSURE MONITOR
    K050697 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR
    K040309 DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862
    K031582 WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20
    Search all 21 clearances from NIHON SEIMITSU SOKKI CO., LTD. →