BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ABL90 FLEX PLUS System

    K Number: K241037 · Decision Jan 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    88
    Applicant Total
    5
    Review Days
    273

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    Basic Information

    Device Name
    ABL90 FLEX PLUS System
    K Number
    K241037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1600
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiometer Medicals Aps
    Date Received
    April 16, 2024
    Decision Date
    January 14, 2025
    Product Code
    CEM
    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
    CEM Electrode, Ion Specific, Potassium

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