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

    ZEE SPHYGMOMANOMETER

    K Number: K823501 · Decision Jan 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    8
    Review Days
    58

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    Basic Information

    Device Name
    ZEE SPHYGMOMANOMETER
    K Number
    K823501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Zee Medical Products Co., Inc.
    Date Received
    November 24, 1982
    Decision Date
    January 21, 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

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    Other Clearances by Zee Medical Products Co., Inc.

    K Number Device Name
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    K812564 ZEE LIFE SUPPORT AIR PANTS
    K812342 ZEE EXTRICATION DEVICE
    K812284 ZEE ELECTRODE-GEL
    K812022 ZEE MANUAL RESUSCITATOR