Cleared Traditional

MAICO MA790 AUDIOMETER

K930112 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat
Aug 1993
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K930112 is an FDA 510(k) clearance for the MAICO MA790 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 August 5, 1993, 206 days after receiving the submission on January 11, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number K930112 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1993
Decision Date August 05, 1993
Days to Decision 206 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