510(k) K843071

ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR by Primrose Medical, Inc. — Product Code BZT

K843071 is an FDA 510(k) premarket notification submitted by Primrose Medical, Inc. for the device "ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR". The FDA issued a decision of Substantially Equivalent on August 24, 1984. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Primrose Medical, Inc. has at least 10 other 510(k) clearances on record.