510(k) K991953

MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION by Engineered Medical Systems — Product Code BTM

K991953 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION". The FDA issued a decision of Substantially Equivalent on July 1, 1999. 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.