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

    HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]

    K Number: K993128 · Decision Nov 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    131
    Registration Numbers
    131
    Same Product Code
    400
    Applicant Total
    8
    Review Days
    64

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    Basic Information

    Device Name
    HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]
    K Number
    K993128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Hero Network, Inc.
    Date Received
    September 20, 1999
    Decision Date
    November 23, 1999
    Product Code
    CGA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CGA Glucose Oxidase, Glucose

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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
    K040086 HEALTH BUDDY WITH BUDDYLINK