510(k) K822356

MODULAIDE EMERG. CARDIAC LIFE SUPP. KT by Laerdal Medical Corp. — Product Code BTM

K822356 is an FDA 510(k) premarket notification submitted by Laerdal Medical Corp. for the device "MODULAIDE EMERG. CARDIAC LIFE SUPP. KT". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Laerdal Medical Corp. has at least 10 other 510(k) clearances on record.