510(k) K993355

HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 by Hudson Respiratory Care, Inc. — Product Code BTT

K993355 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43". The FDA issued a decision of Substantially Equivalent on May 24, 2000. 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.