FDA Registration
Active
🇺🇸 United States
ATLAS Stim Headbox (NK)
Reg #: 3009391672
·
FEI: 3009391672
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Neuralynx, Inc.
- Registration Number
- 3009391672
- FEI Number
- 3009391672
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 105 Commercial Dr
- City
- Bozeman
- State
- MT
- ZIP
- 59715
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250094
Owner / Operator
- Firm Name
- Neuralynx, Inc.
- Operator Number
- 10038712
- Address
- 105 Commercial Drive
- City
- Bozeman
- State
- MT
- Postal Code
- 59715
- Country
- US
- Correspondent
- Kelly Moeykens
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cortical | GYC | Class 2 | Neurology | No | 2025-04-15 |
Proprietary Names
ATLAS Stim Headbox (NK)
Atlas Headbox Interface Cable (NK)
ATLAS Stim Headbox Software
ASHB FIBER OPTIC DUPLEX CONN 2m
Atlas Headbox Interface Cable (HD)
ASHB FIBER OPTIC DUPLEX CONN 7m
Atlas Headbox Expansion Panel
Atlas Headbox Interface Cable (Touchproof)
Atlas Stim Headbox (Touchproof)
Atlas Stim Headbox (HD)
Establishment Types
Manufacture Medical Device