510(k) K964719

HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR by Hudson Respiratory Care, Inc. — Product Code BTM

K964719 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on February 21, 1997. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.