510(k) K243244

Heated Breathing Tube by Guangdong Eda Technology Co., Ltd. — Product Code BZE

K243244 is an FDA 510(k) premarket notification submitted by Guangdong Eda Technology Co., Ltd. for the device "Heated Breathing Tube". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer), a Class II device regulated under 21 CFR 868.5270.