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

    Libre Rio Continuous Glucose Monitoring System

    K Number: K233861 · Decision Jun 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    184

    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
    Libre Rio Continuous Glucose Monitoring System
    K Number
    K233861
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1355
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diabetes Care
    Date Received
    December 6, 2023
    Decision Date
    June 7, 2024
    Product Code
    SBH
    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
    SBH Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

    Similar 510(k) Clearances

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

    Stelo Glucose Biosensor System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Abbott Diabetes Care

    K Number Device Name
    K130094 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM