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

    NICOLET VERSALAB

    K Number: K010521 · Decision Mar 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    8
    Review Days
    15

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    Basic Information

    Device Name
    NICOLET VERSALAB
    K Number
    K010521
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nicolet Biomedical
    Date Received
    February 22, 2001
    Decision Date
    March 9, 2001
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

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