Cleared Traditional

VESTIBULAR ANALYSIS APPARATUS

K121590 · Capacity Sports, LLC · Ear, Nose, Throat

Sep 2012

Decision

112d

Days

—

Risk

About This 510(k) Submission

K121590 is an FDA 510(k) clearance for the VESTIBULAR ANALYSIS APPARATUS, a Apparatus, Vestibular Analysis, submitted by Capacity Sports, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on September 20, 2012, 112 days after receiving the submission on May 31, 2012. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number	K121590 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2012
Decision Date	September 20, 2012
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF