Cleared Traditional

ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK

K983352 · Otodynamics, Ltd. · Ear, Nose, Throat
Dec 1998
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K983352 is an FDA 510(k) clearance for the ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK, a Audiometer (Class II — Special Controls, product code EWO), submitted by Otodynamics, Ltd. (Crofton, US). The FDA issued a Cleared decision on December 11, 1998, 79 days after receiving the submission on September 23, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K983352 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 1998
Decision Date December 11, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EWO — Audiometer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1050