510(k) K904943

TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE by Arzco Medical Electronics, Inc. — Product Code BZT

K904943 is an FDA 510(k) premarket notification submitted by Arzco Medical Electronics, Inc. for the device "TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE". The FDA issued a decision of Substantially Equivalent on April 26, 1991. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Arzco Medical Electronics, Inc. has at least 2 other 510(k) clearances on record.