Neurolyser XR (NXR100)— 510(k) DEN250015
UnknownFusmobile, Inc.
FDA 510(k) clearance DEN250015 for Neurolyser XR (NXR100), Unknown on 2025-11-14. Applicant: Fusmobile, Inc.. Device class: 2.
Clearance details
- Applicant
- Fusmobile, Inc.
- Product code
- Code SGN
- Device class
- Class 2
- Regulation
- 21 CFR 882.4420
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Alpharetta, GA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.