510(k) K133957

DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE by Galemed Corp. — Product Code BYE

K133957 is an FDA 510(k) premarket notification submitted by Galemed Corp. for the device "DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE". The FDA issued a decision of Substantially Equivalent on April 14, 2014. The device falls under product code BYE (Attachment, Breathing, Positive End Expiratory Pressure), a Class II device regulated under 21 CFR 868.5965. Galemed Corp. has at least 6 other 510(k) clearances on record.