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

    ACCU-CHEK Connect Diabetes Management App

    K Number: K150910 · Decision Jun 3, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    54
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    ACCU-CHEK Connect Diabetes Management App
    K Number
    K150910
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diabetes Care, Inc.
    Date Received
    April 3, 2015
    Decision Date
    June 3, 2015
    Product Code
    NDC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NDC Calculator, Drug Dose

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    Other Clearances by Roche Diabetes Care, Inc.

    K Number Device Name
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    K220849 Accu-Chek Safe-T-Pro Plus Lancing Device
    K203711 IWL2020 Blood Glucose Monitoring System
    K220608 Accu-Chek FastClix Blood Lancing System
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    K214022 Accu-Chek Softclix Blood Lancing System
    K160944 ACCU-CHEK Guide Blood Glucose Monitoring System