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510(k) Data Aggregation

    K Number
    K121929
    Device Name
    ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
    Manufacturer
    Date Cleared
    2013-01-17

    (199 days)

    Product Code
    Regulation Number
    880.6775
    Why did this record match?
    Product Code :

    FRZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Zephyr "x-series" Patient Positioning and Transfer System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI, and external beam radiation therapy treatment with electrons, photons or protons, as well as other procedures requiring transfer of a patient.
    Device Description
    The Zephyr "x-series" Patient Positioning and Transfer System functions as an accessory to support a patient and positioning devices during imaging and radiation therapy procedures, and other procedures requiring the transfer of a patient. The Zephyr "x-series" Patient Positioning and Transfer System utilizes forced air as a low-friction bearing to transfer patients from one flat surface to another, eliminating the need to manually lift the patient.
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