BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883

    K Number: K951977 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    180

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    Basic Information

    Device Name
    DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
    K Number
    K951977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Integrated Display Technology, Ltd.
    Date Received
    April 27, 1995
    Decision Date
    October 24, 1995
    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 Integrated Display Technology, Ltd.

    K Number Device Name
    K941490 BLOOD PRESSURE METER MODEL NO. BPM888
    K942336 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K894627 BT-338N ELECTRONIC CLINICAL THERMOMETER
    K853130 INTEGRATED DISPLAY TECHNOLOGY LTD.