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

BK230986 - ePROGESA v5.0.3

510(k) Number: BK230986
Applicant: MAK-SYSTEM Group Ltd.
Device Name: ePROGESA v5.0.3
Decision Date: 11/3/2023

Supporting Documents

BK230986 Letter
BK230986 Summary

Top