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

    NORELCO ELECTRONIC DIGITAL BLOOD PRESS

    K Number: K830684 · Decision May 18, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    15
    Review Days
    75

    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
    NORELCO ELECTRONIC DIGITAL BLOOD PRESS
    K Number
    K830684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    North American Philips Corp.
    Date Received
    March 4, 1983
    Decision Date
    May 18, 1983
    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

    Similar 510(k) Clearances

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

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

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

    Other Clearances by North American Philips Corp.

    K Number Device Name
    K842486 ELECTRONIC DIGITAL BP METER HC 3001
    K841489 NORELCO ELECTRONIC DIGITAL BP METER
    K833755 ELECTRONIC DIGITAL FEVER THERMOMETER
    K830715 NORELCO VIBRATING BOARD V900
    K830685 NORELCO DELUXE DIGITAL BLOOD PRESSURE
    K830687 NORELCO ELECTRONIC ANALOG BLOOD PRESS
    K830686 ANEROID BLOOD PRESSURE CUFF #HC1400
    K813451 UVA FLUORESCENT TANNING LAMPS
    K811891 NORELCO MASSAGER PLUS HEAT BELT
    K811636 NORELCO ELECTRONIC BLOOD PRESSURE METER
    Search all 15 clearances from North American Philips Corp. →