510(k) K153026

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement by Medtec, Inc. D/B/A Civco Medical Solutions — Product Code IYE

K153026 is an FDA 510(k) premarket notification submitted by Medtec, Inc. D/B/A Civco Medical Solutions for the device "Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement". The FDA issued a decision of Substantially Equivalent on May 25, 2016. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.