FDA Registration
Active
🇺🇸 United States
Vektor Computational ECG Mapping System (VMap)
Reg #: 3002672225
·
FEI: 3002672225
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPECTRUM ASSEMBLY INC.
- Registration Number
- 3002672225
- FEI Number
- 3002672225
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6300 Yarrow Dr, SUITE 100
- City
- Carlsbad
- State
- CA
- ZIP
- 92011
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211546
Owner / Operator
- Firm Name
- SPECTRUM ASSEMBLY INC.
- Operator Number
- 9103619
- Address
- 6300 Yarrow Dr, Suite 100
- City
- Carlsbad
- State
- CA
- Postal Code
- 92011
- Country
- US
- Correspondent
- MICHAEL - BALDWIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2021-11-22 |
Proprietary Names
Vektor Computational ECG Mapping System (VMap)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)