510(k) K900273

TRACH CARE MDI ADAPTER by Ballard Medical Products — Product Code CAF

K900273 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "TRACH CARE MDI ADAPTER". The FDA issued a decision of Substantially Equivalent on August 29, 1990. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Ballard Medical Products has at least 10 other 510(k) clearances on record.