510(k) K032170

TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 by Medical Industries America, Inc. — Product Code CAF

K032170 is an FDA 510(k) premarket notification submitted by Medical Industries America, Inc. for the device "TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000". The FDA issued a decision of Substantially Equivalent on May 28, 2004. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medical Industries America, Inc. has at least 10 other 510(k) clearances on record.