AccurECG Analysis System (v2.0)— 510(k) K252361

Substantially Equivalent

Accurkardia, Inc.

FDA 510(k) clearance K252361 for AccurECG Analysis System (v2.0), Substantially Equivalent on 2025-12-22. Applicant: Accurkardia, Inc..

Clearance details

Applicant: Accurkardia, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2025-07-29
Decision date: 2025-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.