510(k) K953815

5 LPM OXYGEN CONCENTRATOR by Devilbiss Health Care, Inc. — Product Code CAW

K953815 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "5 LPM OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on November 9, 1995. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.