510(k) clearance
MyoVista wavECG (DG-200-B15-003)
- 510(k) number
- K260005
- Applicant
- HeartSciences, Inc.
- Decision date
- Oct 5, 2026
- Date received
- Jan 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DPS
- Device type
- Electrocardiograph
- Device class
- Class II
- Regulation
- 21 CFR 870.2340
- Advisory committee
- Cardiovascular
- Statement or summary
- Statement
- Third party
- N
- Location
- Southlake, TX, US