Cleared Traditional

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER

K905704 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Apr 1991

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K905704 is an FDA 510(k) clearance for the MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER, a Tester, Auditory Impedance (Class II — Special Controls, product code ETY), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 1991, 130 days after receiving the submission on December 21, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K905704 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 1990
Decision Date	April 30, 1991
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—