Cleared Traditional

2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY

K890842 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Jun 1989
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K890842 is an FDA 510(k) clearance for the 2400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY, a Audiometer (Class II — Special Controls, product code EWO), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 7, 1989, 106 days after receiving the submission on February 21, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K890842 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1989
Decision Date June 07, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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