EASY ECG PC BASED ELECTROCARDIOGRAPH— 510(k) K972996

Substantially Equivalent

Ates Medical S.R.L.

FDA 510(k) clearance K972996 for EASY ECG PC BASED ELECTROCARDIOGRAPH, Substantially Equivalent on 1998-04-28. Applicant: Ates Medical S.R.L..

Clearance details

Applicant: Ates Medical S.R.L.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1997-08-12
Decision date: 1998-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Granada Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.