510(k) K012037

HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 by Airsep Corp. — Product Code CAW

K012037 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009". The FDA issued a decision of Substantially Equivalent on January 17, 2002. 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.