510(k) K893034

VHS 820 HUMIDIFIER, MODIFICATION by Bear Medical Systems, Inc. — Product Code BTT

K893034 is an FDA 510(k) premarket notification submitted by Bear Medical Systems, Inc. for the device "VHS 820 HUMIDIFIER, MODIFICATION". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Bear Medical Systems, Inc. has at least 10 other 510(k) clearances on record.