510(k) K071904

DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) by Carleton Life Support Systems, Inc. — Product Code CAW

K071904 is an FDA 510(k) premarket notification submitted by Carleton Life Support Systems, Inc. for the device "DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)". The FDA issued a decision of Substantially Equivalent on October 25, 2007. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Carleton Life Support Systems, Inc. has at least 2 other 510(k) clearances on record.