510(k) K881625

CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL by Respiratory Care, Inc. — Product Code BZE

K881625 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL". The FDA issued a decision of Substantially Equivalent on June 21, 1988. 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. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.