Cleared Traditional

MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION

K953161 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Jul 1995

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K953161 is an FDA 510(k) clearance for the MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION, 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 July 24, 1995, 17 days after receiving the submission on July 7, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1090.

Submission Details

510(k) Number	K953161 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1995
Decision Date	July 24, 1995
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement