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

    ROTA DATAMATE I

    K Number: K935945 · Decision Apr 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    127

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    Basic Information

    Device Name
    ROTA DATAMATE I
    K Number
    K935945
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1860
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rota Systems,Inc.
    Date Received
    December 13, 1993
    Decision Date
    April 19, 1994
    Product Code
    HMF
    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
    HMF Stand, Instrument, Ac-Powered, Ophthalmic

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