510(k) K043407

INF 4160, MODEL D-FJ27F by Fuji Dynamics Limited — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2005
Date Received
December 10, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type