510(k) K031375

BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 by Besmed Health Business Corp — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
April 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type