Cleared Traditional

AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID

K890993 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Oct 1989
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K890993 is an FDA 510(k) clearance for the AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID, a Audiometer (Class II — Special Controls, product code EWO), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 12, 1989, 227 days after receiving the submission on February 27, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K890993 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1989
Decision Date October 12, 1989
Days to Decision 227 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