FDA Registration
Active
🇬🇧 United Kingdom
Hypotension Decision Assist HDA-OR2
Reg #: 3016585366
·
FEI: 3016585366
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DIRECTED SYSTEMS LTD
- Registration Number
- 3016585366
- FEI Number
- 3016585366
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 47-51 Norfolk Street
- City
- Cambridge Cambridgeshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K212529
Owner / Operator
- Firm Name
- Directed Systems Ltd
- Operator Number
- 10062519
- Address
- 47-51 Norfolk Street
- City
- Cambridge
- State
- Cambridgeshire
- Postal Code
- CB1 2LD
- Country
- GB
- Correspondent
- Mark S Leaning
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | Class 2 | Cardiovascular | No | 2021-12-21 |
Proprietary Names
Hypotension Decision Assist HDA-OR2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility