510(k) K260005
K260005 is an FDA 510(k) premarket notification submitted by HeartSciences, Inc. for the device "MyoVista wavECG (DG-200-B15-003)". The FDA issued a decision of Substantially Equivalent on Oct 5, 2026. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2026
- Date Received
- Jan 2, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)