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

    MICROJET CRONO PCA

    K Number: K013822 · Decision May 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    10
    Review Days
    173

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    Basic Information

    Device Name
    MICROJET CRONO PCA
    K Number
    K013822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cane S.R.L.
    Date Received
    November 16, 2001
    Decision Date
    May 8, 2002
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

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    Other Clearances by Cane S.R.L.

    K Number Device Name
    K091042 CRONO S-PID 50
    K052218 CRONO FIVE AND CRONO PCA 50
    K052219 CRONO GO.
    K052217 CRONO SUPER PID
    K042085 CRONO F
    K041414 CRONO AND CRONO, MODEL 30
    K013840 MICROJET CRONO PAR AND CRONO APO-GO
    K013234 MICROJET CRONO
    K013807 MICROJET QUARK, MODEL U100 OR U40