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510(k) Data Aggregation

    K Number
    K092858
    Device Name
    SAFERSONIC SONOGRAPHY COVER
    Date Cleared
    2009-11-10

    (55 days)

    Product Code
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFERSONIC MEDIZINPRODUKTE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Safersonic® Sonography Cover is intended to be used as a sterile, single-use protective cover of an ultrasonic transducer. The Safersonic provides a sterile, microbial barrier between the transducer and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulates to the patient. The Safersonic Covers are for use during procedures with sector, linear, intravaginal and rectal transducers.
    Device Description
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