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

    NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)

    K Number: K904499 · Decision Jul 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    42
    Review Days
    273

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    Basic Information

    Device Name
    NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
    K Number
    K904499
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3040
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ackrad Laboratories
    Date Received
    October 1, 1990
    Decision Date
    July 1, 1991
    Product Code
    KFG
    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
    KFG Antiserum, Positive Control, Aspergillus Spp.

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