FDA Registration
Active
🇺🇸 United States
Wrist Actigraph
Reg #: 3029922
·
FEI: 3001452666
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CONTROLTEK, INC.
- Registration Number
- 3029922
- FEI Number
- 3001452666
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3905 NE 112TH AVE.
- City
- Vancouver
- State
- WA
- ZIP
- 98682
- Country
- US
Regulatory Submissions
- 510(k) Number
- K854030
Owner / Operator
- Firm Name
- CONTROLTEK, INC.
- Operator Number
- 9023255
- Address
- 3905 NE 112TH AVE., --
- City
- Vancouver
- State
- WA
- Postal Code
- 98682
- Country
- US
- Correspondent
- Janine R Holder
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2014-12-08 |
Proprietary Names
Wrist Actigraph
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)