FDA Registration
Active
🇺🇸 United States
UltraPro S100 with Integrated Ultrasound
Reg #: 3010611950
·
FEI: 3010611950
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Natus Neurology Incorporated
- Registration Number
- 3010611950
- FEI Number
- 3010611950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3150 Pleasant View Road
- City
- Middleton
- State
- WI
- ZIP
- 53562
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243495
Owner / Operator
- Firm Name
- Natus Medical Incorporated
- Operator Number
- 9004873
- Address
- 3150 Pleasant View Road
- City
- Middleton
- State
- WI
- Postal Code
- 53562
- Country
- US
- Correspondent
- Sanjay Mehta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Photic, Evoked Response | GWE | Class 2 | Neurology | No | 2025-01-24 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2025-01-24 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-24 |
| Stimulator, Mechanical, Evoked Response | GZP | Class 2 | Neurology | No | 2025-01-24 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-24 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2025-01-24 |
| Stimulator, Auditory, Evoked Response | GWJ | Class 2 | Neurology | No | 2025-01-24 |
Proprietary Names
UltraPro S100 with Integrated Ultrasound
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility