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510(k) K121590

VESTIBULAR ANALYSIS APPARATUS by Capacity Sports, LLC — Product Code LXV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2012
Date Received
May 31, 2012
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

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