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

    HEALTH BUDDY WITH BUDDYLINK

    K Number: K040086 · Decision Mar 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    8
    Review Days
    54

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    Basic Information

    Device Name
    HEALTH BUDDY WITH BUDDYLINK
    K Number
    K040086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Hero Network, Inc.
    Date Received
    January 16, 2004
    Decision Date
    March 10, 2004
    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 Health Hero Network, Inc.

    K Number Device Name
    K080091 MODIFICATION TO:HEALTH BUDDY APPLIANCE
    K070543 MODIFICATION TO HEALTH BUDDY APPLIANCE
    K063612 MODIFICATION TO HEALTH BUDDY APPLIANCE
    K060843 MODIFICATION TO HEALTH BUDDY APPLIANCE
    K050567 HEALTH BUDDY APPLIANCE
    K042273 MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
    K993128 HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]