510(k) K951882

ECO CHECK (ECOVALVE AND OXYGEN MONITOR) by Airsep Corp. — Product Code CAW

K951882 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "ECO CHECK (ECOVALVE AND OXYGEN MONITOR)". The FDA issued a decision of Substantially Equivalent on October 16, 1995. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Airsep Corp. has at least 10 other 510(k) clearances on record.