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

    MODIFICATION TO:HEALTH BUDDY APPLIANCE

    K Number: K080091 · Decision Feb 5, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    190
    Applicant Total
    8
    Review Days
    22

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    Basic Information

    Device Name
    MODIFICATION TO:HEALTH BUDDY APPLIANCE
    K Number
    K080091
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2910
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Hero Network, Inc.
    Date Received
    January 14, 2008
    Decision Date
    February 5, 2008
    Product Code
    DRG
    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
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

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    Other Clearances by Health Hero Network, Inc.

    K Number Device Name
    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
    K040086 HEALTH BUDDY WITH BUDDYLINK
    K993128 HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]