510(k) K111050

ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR by Starboard Medical, LLC — Product Code BZT

K111050 is an FDA 510(k) premarket notification submitted by Starboard Medical, LLC for the device "ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR". The FDA issued a decision of Substantially Equivalent on April 12, 2012. 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.