510(k) K150591

Besmed Reusable Jet Nebulizer by Besmed Health Business Corp — Product Code CAF

K150591 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "Besmed Reusable Jet Nebulizer". The FDA issued a decision of Substantially Equivalent on June 30, 2015. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.