CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H— 510(k) K230834

Substantially Equivalent

Trismed Co., Ltd.

FDA 510(k) clearance K230834 for CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H, Substantially Equivalent on 2023-11-21. Applicant: Trismed Co., Ltd..

Clearance details

Applicant: Trismed Co., Ltd.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2023-03-27
Decision date: 2023-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

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.