BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇰 Pakistan

    OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS

    K Number: K131719 · Decision Oct 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
    K Number
    K131719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Devices (Pvt) , Ltd.
    Date Received
    June 12, 2013
    Decision Date
    October 30, 2013
    Product Code
    HLJ
    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
    HLJ Ophthalmoscope, Battery-Powered

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