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510(k) Data Aggregation

    K Number
    K110326
    Device Name
    OSRAM ITOS
    Manufacturer
    OSRAM SYLVANIA, INC.
    Date Cleared
    2011-10-27

    (266 days)

    Product Code
    ERA
    Regulation Number
    874.4770
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSRAM SYLVANIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSRAM ITOS O-03100 is intended to provide illumination of the ear canal and tympanic membrane for observation. It is intended for over-the-counter (OTC) use.
    Device Description
    The OSRAM ITOS O-03100 is an optional accessory lamp for use in compatible Welch Allyn otoscopes (Models 20000, 20200, 21700, 25020). The OSRAM ITOS O-03100 utilizes light emitting diode (LED) technology.
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