510(k) K110398

RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS by Respironics, Inc. — Product Code BZE

K110398 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS". The FDA issued a decision of Substantially Equivalent on June 1, 2011. 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. Respironics, Inc. has at least 10 other 510(k) clearances on record.