MyoVista wavECG (DG-200-B15-003)— 510(k) K260005

Name: FDA 510(k) clearance K260005
Creator: U.S. Food and Drug Administration
Published: 2026-10-05

Substantially Equivalent

HeartSciences, Inc.

FDA 510(k) clearance K260005 for MyoVista wavECG (DG-200-B15-003), Substantially Equivalent on 2026-10-05. Applicant: HeartSciences, Inc.. Device class: 2.

Summary

MyoVista wavECG (DG-200-B15-003) from HeartSciences is filed under DPS, electrocardiographs. The record doesn't say how it differs from a standard ECG device.

Class II, 21 CFR 870.2340. The Cardiovascular panel reviewed it as a Traditional 510(k).

HeartSciences filed from Southlake, Texas. The review clock ran 276 days, from January 2 to October 5, 2026. The record doesn't show how much of that was hold time.

Clearance details

Applicant: HeartSciences, Inc.
Product code: Product code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2026-01-02
Decision date: 2026-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southlake, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

view all

K260250 — QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)2026-09-29
K254255 — S-Patch CardioAI2026-09-25
K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22

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.