510(k) K031908

MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) by Med2000 S.R.L. — Product Code CAF

K031908 is an FDA 510(k) premarket notification submitted by Med2000 S.R.L. for the device "MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)". The FDA issued a decision of Substantially Equivalent on January 14, 2004. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Med2000 S.R.L. has at least 2 other 510(k) clearances on record.