510(k) K041327

MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES by Med2000 S.R.L. — Product Code CAF

K041327 is an FDA 510(k) premarket notification submitted by Med2000 S.R.L. for the device "MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES". The FDA issued a decision of Substantially Equivalent on Jul 20, 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.