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

    OTI MODEL 78-60

    K Number: K951184 · Decision May 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    2
    Review Days
    57

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    Basic Information

    Device Name
    OTI MODEL 78-60
    K Number
    K951184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Oti Medical, LLC
    Date Received
    March 16, 1995
    Decision Date
    May 12, 1995
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Oti Medical, LLC

    K Number Device Name
    K951437 OTI MODEL TLS-60