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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K040367
Device Name MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
Applicant
Electromed, Inc.
502 Sixth Ave. NW
New Prague,  MN  56071
Applicant Contact CHET SIEVERT
Correspondent
Electromed, Inc.
502 Sixth Ave. NW
New Prague,  MN  56071
Correspondent Contact CHET SIEVERT
Regulation Number868.5665
Classification Product Code
BYI  
Date Received02/13/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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