FDA Registration
Active
🇺🇸 United States
AM-2101 Activation Card
Reg #: 1450997
·
FEI: 1450997
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Northgate Technologies Inc.
- Registration Number
- 1450997
- FEI Number
- 1450997
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- ZIP
- 60123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200886
Owner / Operator
- Firm Name
- Northgate Technologies, Inc.
- Operator Number
- 10092614
- Address
- 1591 Scottsdale Court
- City
- Elgin
- State
- IL
- Postal Code
- 60123
- Country
- US
- Correspondent
- Todd Gatto
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-27 |
Proprietary Names
AM-2101 Activation Card
AM-101 StimSite Signal Box
AM-LS1 Adapter
AM-BP1 Adapter
AM-DA1 Adapter
AM-VY1 Adapter
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198