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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    RHA2020

    K Number: K111531 · Decision Jul 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    86
    Applicant Total
    1
    Review Days
    36

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    Basic Information

    Device Name
    RHA2020
    K Number
    K111531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Annidis Health Systems Corp.
    Date Received
    June 2, 2011
    Decision Date
    July 8, 2011
    Product Code
    HLI
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLI Ophthalmoscope, Ac-Powered

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