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In this section: Substantially Equivalent 510(k) Device Information

BK241135 - Aurora Xi Plasmapheresis System Software Version 2.0

510(k) Number: BK241135
Applicant: Fresenius Kabi AG
Device Name: Aurora Xi Plasmapheresis System Software Version 2.0
Decision Date: 1/24/2025

Supporting Documents

BK241135 Letter
BK241135 Summary

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