BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    S-Line

    K Number: K213191 · Decision May 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    237

    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
    S-Line
    K Number
    K213191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barkey GmbH & Co. KG
    Date Received
    September 29, 2021
    Decision Date
    May 24, 2022
    Product Code
    LGZ
    Advisory Committee
    General Hospital
    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
    LGZ Warmer, Thermal, Infusion Fluid

    Similar 510(k) Clearances

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

    °M Warmer System with °M Station

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Fluido Compact System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Fluido® AirGuard System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    °M Warmer System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Fluido Compact Blood and Fluid Warming System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Barkey GmbH & Co. KG

    K Number Device Name
    K071909 PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R