Cleared Traditional

MAICO MA800 AUDIOMETER

K911368 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Jun 1991
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K911368 is an FDA 510(k) clearance for the MAICO MA800 AUDIOMETER, 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 26, 1991, 90 days after receiving the submission on March 28, 1991. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K911368 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1991
Decision Date June 26, 1991
Days to Decision 90 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