Cleared Traditional

AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7

K895310 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Jan 1990
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K895310 is an FDA 510(k) clearance for the AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7, a Audiometer (Class II — Special Controls, product code EWO), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 23, 1990, 147 days after receiving the submission on August 29, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K895310 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1989
Decision Date January 23, 1990
Days to Decision 147 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