510(k) K261694

CORE 300 Digital Stethoscope by Eko Health, Inc. — Product Code DQD

K261694 is an FDA 510(k) premarket notification submitted by Eko Health, Inc. for the device "CORE 300 Digital Stethoscope". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Health, Inc. has at least 3 other 510(k) clearances on record.