510(k) K802231

AIR VIVA II by General Medical Co. — Product Code BTM

K802231 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "AIR VIVA II". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. General Medical Co. has at least 10 other 510(k) clearances on record.