BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    N2000 BASE STATION; N2001 NURSE STATION

    K Number: K020584 · Decision May 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    N2000 BASE STATION; N2001 NURSE STATION
    K Number
    K020584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neptec Design Group, Ltd.
    Date Received
    February 21, 2002
    Decision Date
    May 22, 2002
    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 Neptec Design Group, Ltd.

    K Number Device Name
    K022274 CARECOMPANION PATIENT STATION & NURSE STATION
    K023286 CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
    K012801 N2000 BASE STATION, N2001 NURSE STATION