FDA Device Intelligence
Home › SmartCardia SA › SmartCardia 7L Platform

SmartCardia 7L Platform

SmartCardia SA · Model 1007L · UDI-DI 07640375610041

QYX Prescription
1
510(k) clearances
640
Adverse events (13 deaths)
0
Recalls
13
Facilities

Description

The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.