CARDIOSOFT PC ECG, USB VERSION— 510(k) K052295

Substantially Equivalent

Cardiosoft, L.P.

FDA 510(k) clearance K052295 for CARDIOSOFT PC ECG, USB VERSION, Substantially Equivalent on 2006-01-13. Applicant: Cardiosoft, L.P..

Clearance details

Applicant: Cardiosoft, L.P.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2005-08-23
Decision date: 2006-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.