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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 K053248
Device Name SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
Applicant
ELECTROMED, INC.
103 EDGECUMBE DRIVE
MAHTOMEDI,  MN  55115
Applicant Contact CHET SIEVERT
Correspondent
INTERTEK TESTING SERVICES
70 CODMAN HILL RD.
BOXBOROUGH,  MA  01719
Correspondent Contact NED DEVINE
Regulation Number868.5665
Classification Product Code
BYI  
Date Received11/21/2005
Decision Date 12/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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