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

    ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM

    K Number: K081318 · Decision Jun 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    168
    Registration Numbers
    169
    Same Product Code
    507
    Applicant Total
    42
    Review Days
    28

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    Basic Information

    Device Name
    ONETOUCH ZOOM DIABETES MANAGEMENT PROGRAM
    K Number
    K081318
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1345
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifescan, Inc.
    Date Received
    May 12, 2008
    Decision Date
    June 9, 2008
    Product Code
    NBW
    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
    NBW System, Test, Blood Glucose, Over The Counter

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    Other Clearances by Lifescan, Inc.

    K Number Device Name
    K132618 ONETOUCH REVEAL
    K120558 ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
    K093745 ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
    K082590 SYMPHONY METER REMOTE
    K082513 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
    K073231 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
    K072543 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
    K062195 MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
    K061118 ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
    K053529 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
    Search all 42 clearances from Lifescan, Inc. →