510(k) K173280

Neonatal ConchaSmart Breathing Circuits by Teleflexmedical, Inc. — Product Code BZE

K173280 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "Neonatal ConchaSmart Breathing Circuits". The FDA issued a decision of Substantially Equivalent on August 2, 2018. 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. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.