510(k) K071973

EPLEY OMNIAX by Vesticon — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
July 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Vestibular Analysis
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type