510(k) K844420

MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR by Med-Life, Inc. — Product Code BTM

K844420 is an FDA 510(k) premarket notification submitted by Med-Life, Inc. for the device "MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Med-Life, Inc. has at least 2 other 510(k) clearances on record.