510(k) K040202

SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM by Salter Labs — Product Code BZD

K040202 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 2005. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Salter Labs has at least 10 other 510(k) clearances on record.