510(k) K141087

INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF by Intersurgical Incorporated — Product Code CAH

K141087 is an FDA 510(k) premarket notification submitted by Intersurgical Incorporated for the device "INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF". The FDA issued a decision of Substantially Equivalent on February 12, 2015. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Intersurgical Incorporated has at least 2 other 510(k) clearances on record.