Data / Medical devices / Switzerland / Smartcardia SA
Smartcardia SA: FDA-registered device maker in Lausanne Vaud, Switzerland, 2 510(k) clearances
Smartcardia SA is registered with the FDA (registration 3029904429) in Lausanne Vaud, Switzerland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 31, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029904429
- Address
- EPFL Innovation Park, Lausanne Vaud, Switzerland, 1015
- Owner or operator
- SmartCardia SA (10088984)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 26, 2023
- Registered through
- 2026
- Brand names listed
- 7L Platform, SmartCardia 7L Platform
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Outpatient Cardiac Telemetry | QYX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| October 31, 2024 | K240653 | SmartCardia 7L Platform (MCT) | QYX | Substantially Equivalent | Smartcardia SA | accessdata.fda.gov |
| August 30, 2023 | K231276 | SmartCardia 7L Platform | DSI | Substantially Equivalent | Smartcardia SA | accessdata.fda.gov |
Compare with other makers
- All makers of Detector And Alarm, Arrhythmia
- All makers of Outpatient Cardiac Telemetry
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
Updated October 31, 2024. 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.