FDA Registration
Active
🇺🇸 United States
ATLAS Neurophysiology System
Reg #: 3009391672
·
FEI: 3009391672
·
Expires 2025
Products
1
Proprietary Names
1
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
- K110967
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 |
|---|---|---|---|---|---|
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2011-11-04 |
Proprietary Names
ATLAS Neurophysiology System
Establishment Types
Manufacture Medical Device