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

    AUTOMATED OPHTHALMICS SOFTIPS

    K Number: K992998 · Decision Jan 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    1
    Review Days
    125

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    Basic Information

    Device Name
    AUTOMATED OPHTHALMICS SOFTIPS
    K Number
    K992998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Automated Ophthalmics, Inc.
    Date Received
    September 7, 1999
    Decision Date
    January 10, 2000
    Product Code
    HKY
    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
    HKY Tonometer, Manual

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