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

    MODIFICATION TO HEALTH BUDDY APPLIANCE

    K Number: K060843 · Decision Apr 20, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    8
    Review Days
    23

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    Basic Information

    Device Name
    MODIFICATION TO HEALTH BUDDY APPLIANCE
    K Number
    K060843
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Hero Network, Inc.
    Date Received
    March 28, 2006
    Decision Date
    April 20, 2006
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

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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
    K050567 HEALTH BUDDY APPLIANCE
    K042273 MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY
    K040086 HEALTH BUDDY WITH BUDDYLINK
    K993128 HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]