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510(k) Data Aggregation
K Number
K121929Device Name
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
Manufacturer
Date Cleared
2013-01-17
(199 days)
Regulation Number
880.6775Why 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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