510(k) K120815

INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE by Philips Medical Systems — Product Code FPD

K120815 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on March 6, 2013. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Philips Medical Systems has at least 10 other 510(k) clearances on record.