510(k) K132967

3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP by 3B Medical, Inc. — Product Code BZD

K132967 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP". The FDA issued a decision of Substantially Equivalent on December 6, 2013. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. 3B Medical, Inc. has at least 9 other 510(k) clearances on record.