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

    DISETRONIC PEN P100

    K Number: K993666 · Decision Nov 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    17
    Review Days
    21

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    Basic Information

    Device Name
    DISETRONIC PEN P100
    K Number
    K993666
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disetronic Medical Systems
    Date Received
    November 1, 1999
    Decision Date
    November 22, 1999
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Disetronic Medical Systems

    K Number Device Name
    K013782 DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
    K994186 DISETRONIC D-TRON INSULIN INFUSION PUMP
    K994197 DISENTRONIC PENFINE INJECTION PEN NEEDLE
    K991376 DAHEDI INSULIN INFUSION PUMP
    K990259 DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
    K982966 DISETRONIC PEN
    K982399 DISETRONIC PENFINE INJECTION PEN NEEDLE
    K973339 DISETRONIC PENFINE INJECTION PEN NEEDLE
    K973044 DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
    K961975 DISETRONIC D-MODEM
    Search all 17 clearances from Disetronic Medical Systems →