510(k) K140134

ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE by Starboard Medical, LLC — Product Code BZT

K140134 is an FDA 510(k) premarket notification submitted by Starboard Medical, LLC for the device "ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE". The FDA issued a decision of Substantially Equivalent on June 16, 2014. The device falls under product code BZT (Stethoscope, Esophageal, With Electrical Conductors), a Class II device regulated under 21 CFR 868.1920. Starboard Medical, LLC has at least 2 other 510(k) clearances on record.