510(k) K881087

LIFEGUARD SINGLE USE MANUAL RESUSCITATORS by Lifeguard Medical Products, Inc. — Product Code BTM

K881087 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "LIFEGUARD SINGLE USE MANUAL RESUSCITATORS". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.