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

Name: FDA 510(k) clearance K230834
Creator: U.S. Food and Drug Administration
Published: 2023-11-21

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.. Device class: 2.

Clearance details

Applicant: Trismed Co., Ltd.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
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 ↗

Recent devices under product code DPS

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K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

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.