510(k) K230111

CORE 500 Digital Stethoscope by Eko Devices, Inc. — Product Code DQD

K230111 is an FDA 510(k) premarket notification submitted by Eko Devices, Inc. for the device "CORE 500 Digital Stethoscope". The FDA issued a decision of Substantially Equivalent on May 26, 2023. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Eko Devices, Inc. has at least 5 other 510(k) clearances on record.