FDA Registration
Active
🇺🇸 United States
SPARK Scan
Reg #: 3029984080
·
FEI: 3029984080
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPARK NEURO, INC.
- Registration Number
- 3029984080
- FEI Number
- 3029984080
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 212 W. 18th Street, 17a
- City
- New York
- State
- NY
- ZIP
- 10011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231457
Owner / Operator
- Firm Name
- Spark Neuro, Inc.
- Operator Number
- 10089104
- Address
- 212 W. 18th Street, 17a
- City
- New York
- State
- NY
- Postal Code
- 10011
- Country
- US
- Correspondent
- Marinela Gombosev
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2023-11-06 |
Proprietary Names
SPARK Scan
Establishment Types
Manufacture Medical Device