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

    HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145

    K Number: K852458 · Decision Dec 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    8
    Review Days
    203

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    Basic Information

    Device Name
    HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145
    K Number
    K852458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Healthteam
    Date Received
    June 10, 1985
    Decision Date
    December 30, 1985
    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 Healthteam

    K Number Device Name
    K890586 INFRARED DELUXE
    K890585 INFRARED HEX
    K890588 GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
    K852459 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175
    K852457 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165
    K852653 HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115
    K852460 GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY