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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K260005
Device Name MyoVista wavECG (DG-200-B15-003)
Applicant
HeartSciences, Inc.
550 Reserve St.
Suite 360
Southlake,  TX  76092
Applicant Contact Isabella Schmitt
Correspondent
HeartSciences, Inc.
550 Reserve St.
Suite 360
Southlake,  TX  76092
Correspondent Contact Isabella Schmitt
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/02/2026
Decision Date 10/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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