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510(k) Data Aggregation

    K Number
    K191491
    Device Name
    EZ-Cover
    Manufacturer
    MedXPress.Pro
    Date Cleared
    2020-06-05

    (366 days)

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

    MedXPress.Pro

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Probe cover can be used to minimize contamination between patient and ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use.
    Device Description
    Not Found
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