510(k) K853146

RESPIR THER HUMID CONTAIN STERILE WATER FOR USP by Automatic Liquid Packaging, Inc. — Product Code BTT

K853146 is an FDA 510(k) premarket notification submitted by Automatic Liquid Packaging, Inc. for the device "RESPIR THER HUMID CONTAIN STERILE WATER FOR USP". The FDA issued a decision of Substantially Equivalent on August 6, 1985. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Automatic Liquid Packaging, Inc. has at least 10 other 510(k) clearances on record.