510(k) K924610

BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT by Engineered Medical Systems — Product Code BTM

K924610 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT". The FDA issued a decision of Substantially Equivalent on April 6, 1993. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Engineered Medical Systems has at least 10 other 510(k) clearances on record.