BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Insulia Diabetes Management Companion

    K Number: K172177 · Decision Nov 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    54
    Applicant Total
    5
    Review Days
    111

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Insulia Diabetes Management Companion
    K Number
    K172177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Voluntis Sa.
    Date Received
    July 19, 2017
    Decision Date
    November 7, 2017
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NDC), ordered by most recent decision date.

    Glucommander

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EndoTool IV Cloud 1.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MiniMed Go App

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UpDoc

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T1D1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EndoTool IV (3.1)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Voluntis Sa.

    K Number Device Name
    K232451 Insulia Bolus Companion
    K202596 Insulia Diabetes Management Companion
    K170669 Insulia Diabetes Management Companion
    K161433 Insulia Diabetes Management Companion