CORCAM HEART MONITOR— 510(k) K140548

Substantially Equivalent

Corcam Technologia, SA

FDA 510(k) clearance K140548 for CORCAM HEART MONITOR, Substantially Equivalent on 2014-05-23. Applicant: Corcam Technologia, SA.

Clearance details

Applicant: Corcam Technologia, SA
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2014-03-04
Decision date: 2014-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.