Cleared Traditional

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)

K070696 · Interacoustics A/S · Neurology

Jun 2007

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K070696 is an FDA 510(k) clearance for the INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME), a Stimulator, Auditory, Evoked Response (Class II — Special Controls, product code GWJ), submitted by Interacoustics A/S (Minnesota, US). The FDA issued a Cleared decision on June 29, 2007, 108 days after receiving the submission on March 13, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1900.

Submission Details

510(k) Number	K070696 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2007
Decision Date	June 29, 2007
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF