Device type
Electrocardiograph
Product code DPS · Class II · 21 CFR 870.2340 · Cardiovascular
Recent 510(k)s
Oct 23, 2026
K260640
Kinetic Software Library
Monebo Technologies, Inc.
- DPS
- Class II
Oct 5, 2026
K260005
MyoVista wavECG (DG-200-B15-003)
HeartSciences, Inc.
- DPS
- Class II
Sep 29, 2026
K260250
QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
QT Medical, Inc.
- DPS
- Class II
Recent recalls
Sep 2, 2026
Z-3012-2026
Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software Version: Midmark IQecg Plugin versions starting with v10 and prior to v10.1.0.…
Midmark Corporation
- DPS
- Class II
- Ongoing