510(k) K040367

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ by Electromed, Inc. — Product Code BYI

K040367 is an FDA 510(k) premarket notification submitted by Electromed, Inc. for the device "MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ". The FDA issued a decision of Substantially Equivalent on April 7, 2004. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Electromed, Inc. has at least 5 other 510(k) clearances on record.