510(k) K140097

AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM by Applied Medical Technology, Inc. — Product Code CBH

K140097 is an FDA 510(k) premarket notification submitted by Applied Medical Technology, Inc. for the device "AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 2014. The device falls under product code CBH (Device, Fixation, Tracheal Tube), a Class I device regulated under 21 CFR 868.5770. Applied Medical Technology, Inc. has at least 10 other 510(k) clearances on record.