510(k) K892221

PULMONARY RESUSCITATOR, MODIFICATION by Life Design Systems, Inc. — Product Code BTM

K892221 is an FDA 510(k) premarket notification submitted by Life Design Systems, Inc. for the device "PULMONARY RESUSCITATOR, MODIFICATION". The FDA issued a decision of Substantially Equivalent on May 18, 1989. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Life Design Systems, Inc. has at least 10 other 510(k) clearances on record.