Cleared Traditional

Eclipse with VEMP

K162037 · Interacoustics A/S · Neurology

Mar 2017

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K162037 is an FDA 510(k) clearance for the Eclipse with VEMP, a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on March 23, 2017, 244 days after receiving the submission on July 22, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number	K162037 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 22, 2016
Decision Date	March 23, 2017
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF