510(k) K021082

ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 by On Site Gas Systems, Inc. — Product Code CAW

K021082 is an FDA 510(k) premarket notification submitted by On Site Gas Systems, Inc. for the device "ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0". The FDA issued a decision of Substantially Equivalent on May 22, 2002. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. On Site Gas Systems, Inc. has at least 8 other 510(k) clearances on record.