Cleared Traditional

GN OTOMETRICS TYPE 1053 FREEFIT

K110286 · Gn Otometrics A/S · Ear, Nose, Throat

Apr 2011

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K110286 is an FDA 510(k) clearance for the GN OTOMETRICS TYPE 1053 FREEFIT, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Gn Otometrics A/S (Schaumburg, US). The FDA issued a Cleared decision on April 28, 2011, 87 days after receiving the submission on January 31, 2011. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number	K110286 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 2011
Decision Date	April 28, 2011
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF