Cleared Traditional

HF MEGA EAR

K960567 · Maxi-Aids, Inc. · Ear, Nose, Throat

Oct 1996

Decision

250d

Days

Class 2

Risk

About This 510(k) Submission

K960567 is an FDA 510(k) clearance for the HF MEGA EAR, a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF), submitted by Maxi-Aids, Inc. (Farmingdale, US). The FDA issued a Cleared decision on October 16, 1996, 250 days after receiving the submission on February 9, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K960567 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1996
Decision Date	October 16, 1996
Days to Decision	250 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement