Neurolyser XR (NXR100)— 510(k) DEN250015

Unknown

Fusmobile, Inc.

FDA 510(k) clearance DEN250015 for Neurolyser XR (NXR100), Unknown on 2025-11-14. Applicant: Fusmobile, Inc..

Clearance details

Applicant: Fusmobile, Inc.
Product code: Code SGN
Advisory panel: Neurology
Date received: 2025-04-25
Decision date: 2025-11-14
Decision: Unknown
Clearance type: Direct
Location: Alpharetta, GA, US

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