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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 K132794
Device Name SMARTVEST AIRWAY CLEARANCE SYSTEM
Applicant
ELECTROMED, INC.
502 SIXTH AVE. N.W.
NEW PRAGUE,  MN  56071
Applicant Contact CHET SIEVERT
Correspondent
ELECTROMED, INC.
502 SIXTH AVE. N.W.
NEW PRAGUE,  MN  56071
Correspondent Contact CHET SIEVERT
Regulation Number868.5665
Classification Product Code
BYI  
Date Received09/06/2013
Decision Date 12/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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