Data / Medical devices / United Kingdom / Directed Systems Ltd
Directed Systems Ltd: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 2 510(k) clearances
Directed Systems Ltd is registered with the FDA (registration 3016585366) in Cambridge Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016585366
- Address
- 47-51 Norfolk Street, Cambridge Cambridgeshire, United Kingdom, CB1 2LD
- Owner or operator
- Directed Systems Ltd (10062519)
- Roles
- Specification developer
- First device listed
- February 27, 2020
- Registered through
- 2026
- Brand names listed
- Hypotension Decision Assist (HDA), Hypotension Decision Assist HDA-OR2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 23, 2021 | K212529 | Hypotension Decision Assist Model HDA-OR2 | DXG | Substantially Equivalent | Directed Systems, Ltd. | accessdata.fda.gov |
| November 27, 2019 | K190955 | Hypotension Decision Assist | DXG | Substantially Equivalent | Directed Systems, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.