510(k) K093124

PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 by Cardinal Health 207, Inc. — Product Code BZD

K093124 is an FDA 510(k) premarket notification submitted by Cardinal Health 207, Inc. for the device "PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03". The FDA issued a decision of Substantially Equivalent on March 10, 2010. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Cardinal Health 207, Inc. has at least 4 other 510(k) clearances on record.