510(k) K182196

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth by Imediplus, Inc. — Product Code DQD

K182196 is an FDA 510(k) premarket notification submitted by Imediplus, Inc. for the device "Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth". The FDA issued a decision of Substantially Equivalent on Sep 11, 2018. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Imediplus, Inc. has 2 other 510(k) clearances on record.