BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PULSE/B.P. MONITOR

    K Number: K864411 · Decision Jun 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    6
    Review Days
    229

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    Basic Information

    Device Name
    PULSE/B.P. MONITOR
    K Number
    K864411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pulse Time Products, Ltd.
    Date Received
    November 7, 1986
    Decision Date
    June 24, 1987
    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 Pulse Time Products, Ltd.

    K Number Device Name
    K901392 BP50 BLOOD PRESSURE AND PULSE MONITOR
    K892794 PULSE TIME PRODUCTS LIMITED, PM-2
    K892795 PULSE TIME PRODUCTS LIMITED, PM-3
    K864748 PM-8 HEART RATE MONITOR
    K811425 CARDIACMONITORS