510(k) K961150

DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA by Hudson Respiratory Care, Inc. — Product Code CCK

K961150 is an FDA 510(k) premarket notification submitted by Hudson Respiratory Care, Inc. for the device "DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULA". The FDA issued a decision of Substantially Equivalent on September 10, 1996. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Hudson Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.