510(k) K013421

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES by Lifeguard Medical Products, Inc. — Product Code BZD

K013421 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "LIFEGUARD NASAL CPAP MASK AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 8, 2002. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.