Cleared Traditional

FOCUS VNG/ENG TYPE 1068

K061791 · Gn Otometrics A/S · Neurology

Jul 2006

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K061791 is an FDA 510(k) clearance for the FOCUS VNG/ENG TYPE 1068, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Gn Otometrics A/S (Schaumburg, US). The FDA issued a Cleared decision on July 11, 2006, 15 days after receiving the submission on June 26, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K061791 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 26, 2006
Decision Date	July 11, 2006
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF