An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

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

BK230825 - ALYX 2RBC-LR Kit

510(k) Number: BK230825
Applicant: Fresenius Kabi AG
Device Name: ALYX 2RBC-LR Kit
Decision Date: 4/5/2024

Supporting Documents

BK230825 Letter
BK230825 Summary

Top