BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SIRSCAN

    K Number: K991473 · Decision Nov 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    210

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    Basic Information

    Device Name
    SIRSCAN
    K Number
    K991473
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2850
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intelligence Artificielle Applications
    Date Received
    April 27, 1999
    Decision Date
    November 23, 1999
    Product Code
    KZK
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZK Reader, Zone, Automated

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