Neurolyser XR (NXR100)
FDA 510(k) clearance DEN250015 · decided 2025-11-14
Clearance details
- K-number
- DEN250015
- Device name
- Neurolyser XR (NXR100)
- Applicant
- Fusmobile, Inc.
- Decision
- Unknown
- Date received
- 2025-04-25
- Decision date
- 2025-11-14
- Days to decision
- 203 days
- Clearance type
- Direct
- Product code
- SGN
- Device class
- 2
- Regulation number
- 882.4420
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.