K-number	DEN250015
Device name	Neurolyser XR (NXR100)
Applicant	Fusmobile, Inc.
Product code	SGN
Device class	Class II
Decision date	Nov 14, 2025
Decision	Not Substantially Equivalent
Regulation	882.4420

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Neurolyser XR (NXR100)

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