510(k) K982889

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 by Electromed, Inc. — Product Code BYI

K982889 is an FDA 510(k) premarket notification submitted by Electromed, Inc. for the device "MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000". The FDA issued a decision of Substantially Equivalent on June 1, 1999. 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.