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510(k) K053248

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL by Electromed, Inc. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2005
Date Received
November 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

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