Data / Medical devices / United Kingdom / Hidalgo Limited
Hidalgo Limited: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 1 510(k) clearance
Hidalgo Limited is registered with the FDA (registration 3004196561) in Cambridge Cambridgeshire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004196561
- Address
- Hidalgo Limited, Suite 1, Ground Floor, Progress House Rowles Way, Buckingway Business Park, Swavesey, Cambridge Cambridgeshire, United Kingdom, CB24 4UG
- Owner or operator
- Hidalgo Limited (10032511)
- Roles
- Manufacturer
- First device listed
- February 24, 2012
- Registered through
- 2026
- Brand names listed
- Equivital EQ02
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 17, 2012 | K113054 | EQUIVITAL | MHX | Substantially Equivalent | Hidalgo Limited | accessdata.fda.gov |
Compare with other makers
Updated February 17, 2012. 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.