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

    ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE

    K Number: K100704 · Decision May 14, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    149
    Registration Numbers
    149
    Same Product Code
    847
    Applicant Total
    12
    Review Days
    63

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    Basic Information

    Device Name
    ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
    K Number
    K100704
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disetronic Medical Systems AG
    Date Received
    March 12, 2010
    Decision Date
    May 14, 2010
    Product Code
    FRN
    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
    FRN Pump, Infusion

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    Other Clearances by Disetronic Medical Systems AG

    K Number Device Name
    K070189 ACCU-CHEK ULTRAFLEX INFUSION SET
    K063146 ACCU-CHEK LINKASSIST
    K060876 ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
    K042887 ACCU-CHEK SPIRIT
    K043000 MODIFICATION TO D-TRONPLUS
    K033892 ULTRAFLEX INFUSION SET
    K023471 DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
    K022831 MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
    K021725 DISETRONIC D-TRON INSULIN INFUSION PUMP
    K003977 DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET
    Search all 12 clearances from Disetronic Medical Systems AG →