FDA Registration
Active
🇺🇸 United States
Cortex, Inc.
Reg #: 3013627970
·
FEI: 3013627970
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cortex, Inc.
- Registration Number
- 3013627970
- FEI Number
- 3013627970
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2755 Great America Way Ste 401
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K230008
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Adrienne Bishop
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2025-02-21 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198