510(k) K860180

MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR by Life Support Products, Inc. — Product Code BTM

K860180 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.