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

    NEOSONO 2000

    K Number: K955088 · Decision Jul 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    1
    Review Days
    246

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    Basic Information

    Device Name
    NEOSONO 2000
    K Number
    K955088
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Medical & Dental Corp.
    Date Received
    November 7, 1995
    Decision Date
    July 10, 1996
    Product Code
    LQY
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LQY Locator, Root Apex

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