510(k) K983919

EMS MOUTH TO MASK RESUSCITATORS by Engineered Medical Systems — Product Code CBP

K983919 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "EMS MOUTH TO MASK RESUSCITATORS". The FDA issued a decision of Substantially Equivalent on April 7, 1999. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Engineered Medical Systems has at least 10 other 510(k) clearances on record.