510(k) K090840

VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. by Ventlab Corp. — Product Code CAF

K090840 is an FDA 510(k) premarket notification submitted by Ventlab Corp. for the device "VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.". The FDA issued a decision of Substantially Equivalent on June 25, 2009. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Ventlab Corp. has at least 10 other 510(k) clearances on record.