510(k) K962220

HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER by Marquest Medical Products, Inc. — Product Code BZE

K962220 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on January 14, 1997. 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. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.