Cleared Traditional

GN OTOMETRICS INSERT EARPHONES

K081234 · Gn Otometrics · Ear, Nose, Throat

Jul 2008

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K081234 is an FDA 510(k) clearance for the GN OTOMETRICS INSERT EARPHONES, a Audiometer (Class II — Special Controls, product code EWO), submitted by Gn Otometrics (Schaumburg, US). The FDA issued a Cleared decision on July 14, 2008, 74 days after receiving the submission on May 1, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K081234 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2008
Decision Date	July 14, 2008
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF