510(k) K903138

MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM by Marquest Medical Products, Inc. — Product Code BTT

K903138 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 11, 1990. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.