510(k) K082092

DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE by Galemed Corp. — Product Code BTM

K082092 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE". The FDA issued a decision of Substantially Equivalent on October 15, 2008. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Galemed Corp. has at least 6 other 510(k) clearances on record.