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

    OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER

    K Number: K912522 · Decision Jul 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    48
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
    K Number
    K912522
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Summit Technology, Inc.
    Date Received
    May 22, 1991
    Decision Date
    July 25, 1991
    Product Code
    EQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQH Source, Carrier, Fiberoptic Light

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    Other Clearances by Summit Technology, Inc.

    K Number Device Name
    K980675 SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
    K926470 LASER AND EMPHASIS SCLEROSTOMY TIP
    K915651 OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM
    K904470 SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE