Cleared Traditional

MA25 - PORTABLE AUDIOMETER, MODIFICATION

K926439 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Aug 1993

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K926439 is an FDA 510(k) clearance for the MA25 - PORTABLE AUDIOMETER, MODIFICATION, 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, 225 days after receiving the submission on December 23, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1050.

Submission Details

510(k) Number	K926439 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1992
Decision Date	August 05, 1993
Days to Decision	225 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement