510(k) K923946

CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER by Hudson Respiratory Care, Inc. — Product Code BTT

K923946 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "CONCHATHERM IV HEATED MOLECULAR HUMIDIFIER". The FDA issued a decision of Substantially Equivalent on October 18, 1994. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.