FDA Registration
Active
🇺🇸 United States
Component Neuromonitoring System
Reg #: 3010611950
·
FEI: 3010611950
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
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
- K080217
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 |
|---|---|---|---|---|---|
| Oximeter, Tissue Saturation | MUD | Class 2 | Cardiovascular | No | 2023-08-09 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2023-08-09 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2023-08-09 |
| Burst Suppression Detection Software For Electroencephalograph | ORT | Class 2 | Neurology | No | 2023-08-09 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2023-08-09 |
| Amplitude-Integrated Electroencephalograph | OMA | Class 2 | Neurology | No | 2023-08-09 |
Proprietary Names
Component Neuromonitoring System
Establishment Types
Manufacture Medical Device