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

    ADAPT, MODEL AX-03SN

    K Number: K100954 · Decision Feb 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    324

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ADAPT, MODEL AX-03SN
    K Number
    K100954
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1050
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apeliotus Vision Science, Inc.
    Date Received
    April 7, 2010
    Decision Date
    February 25, 2011
    Product Code
    OUM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OUM Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation