510(k) K060439

LUNG FLUTE by Medical Acoustics, LLC — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2006
Date Received
February 21, 2006
Clearance Type
Traditional
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