ECG100+, ECG200+— 510(k) K160840

Substantially Equivalent

Cardioline S.P.A

FDA 510(k) clearance K160840 for ECG100+, ECG200+, Substantially Equivalent on 2016-08-12. Applicant: Cardioline S.P.A.

Clearance details

Applicant: Cardioline S.P.A
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2016-03-28
Decision date: 2016-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spini Di Gardolo, IT

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.