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

    ABL90 FLEX PLUS System

    K Number: K240998 · Decision Dec 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    246

    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
    ABL90 FLEX PLUS System
    K Number
    K240998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1120
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiometer Medicals Aps
    Date Received
    April 11, 2024
    Decision Date
    December 13, 2024
    Product Code
    CHL
    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
    CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

    Similar 510(k) Clearances

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

    ABL90 FLEX PLUS System, safeCLINITUBES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT CG4+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT CG8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Stat Profile Prime Plus Analyzer System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    i-STAT G3+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEM Premier 7000 with IQM3

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

    Other Clearances by Radiometer Medicals Aps

    K Number Device Name
    K252475 ABL90 FLEX PLUS System
    K252488 ABL90 FLEX PLUS System
    K252207 ABL90 FLEX PLUS System, safeCLINITUBES
    K241037 ABL90 FLEX PLUS System