510(k) K082634

VERTIGONE BPPV GOGGLE by Vertigone, Inc. — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2009
Date Received
September 10, 2008
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