510(k) K131707

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

K131707 is an FDA 510(k) premarket notification submitted by 3B Medical, Inc. for the device "3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 22, 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.