510(k) K932799

SINGLE USE MANUAL RESUSCITATOR PEEP VALVE by Engineered Medical Systems — Product Code BYE

K932799 is an FDA 510(k) premarket notification submitted by Engineered Medical Systems for the device "SINGLE USE MANUAL RESUSCITATOR PEEP VALVE". The FDA issued a decision of Substantially Equivalent on September 3, 1993. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Engineered Medical Systems has at least 10 other 510(k) clearances on record.