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

    FORESEE HOME

    K Number: K091579 · Decision Dec 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    204

    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
    FORESEE HOME
    K Number
    K091579
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Notal Vision , Ltd.
    Date Received
    June 2, 2009
    Decision Date
    December 23, 2009
    Product Code
    HPT
    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
    HPT Perimeter, Automatic, Ac-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HPT), ordered by most recent decision date.

    MAIA, MODEL 1

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRUEFIELD ANALYZER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    NOVAVISION, MODEL 2.0

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    KASHA VISUAL FIELD SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all