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

    MTI PHOTOSCREENER

    K Number: K934880 · Decision Apr 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    176

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    Basic Information

    Device Name
    MTI PHOTOSCREENER
    K Number
    K934880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Technology and Innovations, Inc.
    Date Received
    October 12, 1993
    Decision Date
    April 6, 1994
    Product Code
    MMF
    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
    MMF Photorefractor

    Other Clearances by Medical Technology and Innovations, Inc.

    K Number Device Name
    K020512 MTI ST#1 SILICONE PESSARY
    K854354 THE BLEDSOE PASSIVE MOTION EXERCISER