Data / Medical devices / United Kingdom / OBS Medical Ltd
OBS Medical Ltd: FDA-registered device maker in Cirencester Gloucestershire, United Kingdom, 1 510(k) clearance
OBS Medical Ltd is registered with the FDA (registration 3000162901) in Cirencester Gloucestershire, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 15, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3000162901
- Address
- Unit 14 Cirencester Office Park Tetbury Road, Cirencester Gloucestershire, United Kingdom, GL7 6JJ
- Owner or operator
- OBS MEDICAL LIMITED (9051099)
- Roles
- Manufacturer
- First device listed
- November 22, 2012
- Registered through
- 2026
- Brand names listed
- Visensia
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 |
|---|---|---|---|---|---|---|
| June 15, 2011 | K110953 | VISENSIA, VISENSIA WITH ALERT | MHX | Substantially Equivalent | Obs Medical | accessdata.fda.gov |
Compare with other makers
Updated June 15, 2011. 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.