510(k) K970289

COMPRESSOR/NEBULIZER #3650 by Devilbiss Health Care, Inc. — Product Code CAF

K970289 is an FDA 510(k) premarket notification submitted by Devilbiss Health Care, Inc. for the device "COMPRESSOR/NEBULIZER #3650". The FDA issued a decision of Substantially Equivalent on April 15, 1997. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Devilbiss Health Care, Inc. has at least 10 other 510(k) clearances on record.