BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT

    K Number: K801418 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    5
    Review Days
    34

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    Basic Information

    Device Name
    KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT
    K Number
    K801418
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Keeler Optical Products , Ltd.
    Date Received
    June 17, 1980
    Decision Date
    July 21, 1980
    Product Code
    HPS
    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
    HPS Unit, Cryophthalmic

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    Other Clearances by Keeler Optical Products , Ltd.

    K Number Device Name
    K810403 KEELER/KONAN SPECULAR MICROSCOPE
    K792255 NEVYAS AUTOPRESS EYE COMPRESSOR
    K782141 LEVIGATOR, KEELER PHOKO
    K781892 LOCATOR, FOREIGN BODY