FDA Registration
Active
🇺🇸 United States
BrainScope One
Reg #: 3008660657
·
FEI: 3008660657
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BRAINSCOPE
- Registration Number
- 3008660657
- FEI Number
- 3008660657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7648 Standish Place
- City
- Rockville
- State
- MD
- ZIP
- 20855
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181179
Owner / Operator
- Firm Name
- BrainScope Company, Inc.
- Operator Number
- 10039715
- Address
- 7648 Standish Place
- City
- Rockville
- State
- MD
- Postal Code
- 20855
- Country
- US
- Correspondent
- Leslie S Prichep
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Normalizing Quantitative Electroencephalograph Software | OLU | Class 2 | Neurology | No | 2018-12-11 |
| Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | PIW | Class 2 | Neurology | No | 2018-12-11 |
| Computerized Cognitive Assessment Aid | PKQ | Class 2 | Neurology | No | 2018-12-11 |
Proprietary Names
BrainScope One
Establishment Types
Manufacture Medical Device