510(k) K141595

O-TWO E700,O-TWO E600,O-TWO E500 by O-Two Medical Technologies, Inc. — Product Code BTL

K141595 is an FDA 510(k) premarket notification submitted by O-Two Medical Technologies, Inc. for the device "O-TWO E700,O-TWO E600,O-TWO E500". The FDA issued a decision of Substantially Equivalent on March 16, 2015. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. O-Two Medical Technologies, Inc. has at least 7 other 510(k) clearances on record.