Cleared Traditional

SPEECHLINK 100 TYPE 1053

K061104 · Gn Otometrics A/S · Ear, Nose, Throat
May 2006
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K061104 is an FDA 510(k) clearance for the SPEECHLINK 100 TYPE 1053, a Calibrator, Hearing Aid / Earphone And Analysis Systems (Class II — Special Controls, product code ETW), submitted by Gn Otometrics A/S (Taastrup, DK). The FDA issued a Cleared decision on May 3, 2006, 13 days after receiving the submission on April 20, 2006. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3310.

Submission Details

510(k) Number K061104 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2006
Decision Date May 03, 2006
Days to Decision 13 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETW — Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3310

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