510(k) K132794

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2013
Date Received
September 6, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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