Cleared Traditional

OTOFLEX 100 TYE 1012

K033645 · Gn Otometrics A/S · Ear, Nose, Throat

Mar 2004

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K033645 is an FDA 510(k) clearance for the OTOFLEX 100 TYE 1012, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Gn Otometrics A/S (Taastrup, DK). The FDA issued a Cleared decision on March 31, 2004, 132 days after receiving the submission on November 20, 2003. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K033645 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2003
Decision Date	March 31, 2004
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF