FDA Registration
Active
🇺🇸 United States
LABSYSTEM PRO EP Recording System
Reg #: 3004594159
·
FEI: 3004594159
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dedicated Computing LLC
- Registration Number
- 3004594159
- FEI Number
- 3004594159
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- N26W23880 Commerce Circle
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
Regulatory Submissions
- 510(k) Number
- K141185
Owner / Operator
- Firm Name
- Dedicated Computing LLC
- Operator Number
- 10030096
- Address
- N26W23880 Commerce Circle
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
- Correspondent
- Jill Fedor
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2015-07-17 |
Proprietary Names
LABSYSTEM PRO EP Recording System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)