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

    EYE SEE INSTRUMENT

    K Number: K905237 · Decision Feb 14, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    EYE SEE INSTRUMENT
    K Number
    K905237
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4445
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    King Tool, Inc.
    Date Received
    November 16, 1990
    Decision Date
    February 14, 1991
    Product Code
    HPN
    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
    HPN Magnet, Permanent

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