FDA Registration
Active
🇺🇸 United States
Sensor Cap
Reg #: 3036712475
·
FEI: 3036712475
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Forest Devices, Inc.
- Registration Number
- 3036712475
- FEI Number
- 3036712475
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 S Commons Ste 102
- City
- Pittsburgh
- State
- PA
- ZIP
- 15212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242306
Owner / Operator
- Firm Name
- Forest Devices, Inc.
- Operator Number
- 10092992
- Address
- 100 S Commons, Suite 102
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15212
- Country
- US
- Correspondent
- Carmelo R Montalvo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2025-03-13 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | Class 2 | Neurology | No | 2025-03-13 |
| Reduced- Montage Standard Electroencephalograph | OMC | Class 2 | Neurology | No | 2025-03-13 |
Proprietary Names
Sensor Cap
SignalNED Model RE System
SignalNED Model RE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility