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

    OPHTHASONIC A/P III

    K Number: K903666 · Decision Nov 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    18
    Review Days
    97

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    Basic Information

    Device Name
    OPHTHASONIC A/P III
    K Number
    K903666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4250
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Teknar, Inc.
    Date Received
    August 14, 1990
    Decision Date
    November 19, 1990
    Product Code
    HPY
    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
    HPY Unit, Electrolysis, Battery-Powered, Ophthalmic

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    K881850 TEKNAR PERCU-SCAN
    K881605 BIOPSY GUIDE
    K880659 TEKNAR PROSCAN ACCESSORY PROBE
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