CardioSTAT® ECG Test Solution— 510(k) K223049

Name: FDA 510(k) clearance K223049
Creator: U.S. Food and Drug Administration
Published: 2023-03-22

Substantially Equivalent

Icentia, Inc.

FDA 510(k) clearance K223049 for CardioSTAT® ECG Test Solution, Substantially Equivalent on 2023-03-22. Applicant: Icentia, Inc.. Device class: 2.

Clearance details

Applicant: Icentia, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2022-09-29
Decision date: 2023-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSH

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K260157 — LifeLens Physiological Monitor2026-07-09
K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)2026-04-23
K253293 — VitaloJAK Clinic (Model 7100)2025-12-03
K243650 — Zio® monitor (DFG0001)2025-08-15
K243603 — AeviceMD2025-05-05

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.