FDA Registration
Active
🇺🇸 United States
Subdermal Wire Electrode
Reg #: 3008806011
·
FEI: 3008806011
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Ives EEG Solutions
- Registration Number
- 3008806011
- FEI Number
- 3008806011
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 44 Merrimac St
- City
- Newburyport
- State
- MA
- ZIP
- 01950
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062880
Owner / Operator
- Firm Name
- IVES EEG SOLUTIONS, INC.
- Operator Number
- 9082126
- Address
- 44 Merrimac
- City
- Newburyport
- State
- MA
- Postal Code
- 01950
- Country
- US
- Correspondent
- Patrick J Phelan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2007-11-06 |
Proprietary Names
Subdermal Wire Electrode
Establishment Types
Manufacture Medical Device