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

    JOSTRA FLOWPROBE FP-32E

    K Number: K013939 · Decision Dec 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    47
    Applicant Total
    13
    Review Days
    15

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    Basic Information

    Device Name
    JOSTRA FLOWPROBE FP-32E
    K Number
    K013939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jostra AG
    Date Received
    November 29, 2001
    Decision Date
    December 14, 2001
    Product Code
    DPT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DPT Probe, Blood-Flow, Extravascular

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    K014303 JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
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